Product Code: JKA FDA class 2 21 CFR 862.1675

Tubes, Vials, Systems, Serum Separators, Blood Collection

Clinical Chemistry

This device includes tubes, vials, systems, and serum separators used in clinical laboratories for blood collection and specimen preparation, enabling proper separation of serum or plasma from cellular components for downstream biochemical testing. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification to demonstrate substantial equivalence. The product code is JKA, regulated under 21 CFR 862.1675, within the Clinical Chemistry medical specialty.

View on FDA

510(k)s

236

FEI Numbers

218

Registration Numbers

218

Unique Applicants

117

Years Active

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Basic Information

Product Code: JKA
Device Class: FDA class 2
Regulation Number: 862.1675
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 236 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252899	Female Culture Device; Male Culture Device; Transfer Device; Access Device	Jun 02, 2026	Substantially Equivalent	Zhejiang Kindly Medical Device Co., Ltd.
K260128	BD Preset and BD A-Line Arterial Blood Collection Syringes	Apr 15, 2026	Substantially Equivalent	Becton, Dickinson and Company
K252506	BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder	Apr 10, 2026	Substantially Equivalent	Becton, Dickinson and Company
K252378	BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube	Apr 10, 2026	Substantially Equivalent	Becton, Dickinson and Company
K252040	BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes	Mar 13, 2026	Substantially Equivalent	Becton, Dickinson and Company
K251812	Steripath® Flow Blood Collection System	Sep 25, 2025	Substantially Equivalent	Magnolia Medical Technologies
K243207	BD Vacutainer® Eclipse Blood Collection Needle	Jul 03, 2025	Substantially Equivalent	Becton, Dickinson and Company
K250961	Blood collection tube holders	Jun 04, 2025	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K244047	Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)	May 23, 2025	Substantially Equivalent	Venocare, Inc.
K250907	Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set	Apr 30, 2025	Substantially Equivalent	Sol-Millennium Medical, Inc.
K243649	BD Vacutainer® Multiple Sample Luer Adapter	Mar 21, 2025	Substantially Equivalent	Becton, Dickinson and Company
K241586	PIVO Pro Needle-free Blood Collection Device	Feb 27, 2025	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.
K242320	BD Vacutainer® One Use Holder	Nov 01, 2024	Substantially Equivalent	Becton, Dickinson and Company
K233979	VACUETTE® QUICKSHIELD Complete (Plus)	Jul 19, 2024	Substantially Equivalent	Greiner Bio-One North America, Inc.
K232781	Safety Sliding Blood Collection Set	Mar 07, 2024	Substantially Equivalent	Jiangsu Caina Medical Co.,Ltd
K231373	BD Vacutainer® K2 EDTA Blood Collection Tubes	Feb 02, 2024	Substantially Equivalent	Becton, Dickinson and Company
K231282	LifeOutcomes C-Quest Blood Culture Sampling Device	Jan 26, 2024	Substantially Equivalent	Lifeoutcomes, LLC
K231237	BD Vacutainer® Fluoride Blood Collection Tubes	Jan 19, 2024	Substantially Equivalent	Becton, Dickinson and Company
K232881	Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder	Dec 22, 2023	Substantially Equivalent	Jiangsu Kangbao Medical Equipment Co., Ltd.
K230855	BD Vacutainer® Serum Separator (SST) Blood Collection Tubes	Dec 20, 2023	Substantially Equivalent	Becton, Dickinson and Company
K232308	Monarch Blood Collection Set	Dec 04, 2023	Substantially Equivalent	The Monarch Company
K230391	BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube	Dec 01, 2023	Substantially Equivalent	Becton, Dickinson and Company
K213146	Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen	Oct 27, 2023	Substantially Equivalent	Jiangsu Rongye Technology Co., Ltd.
K220458	UltraFlo-R Push Button Blood Collection Set	Sep 29, 2023	Substantially Equivalent	Innovative Medical Technologies, Inc.
K230865	PIVO Pro Needle-free Blood Collection Device	Sep 28, 2023	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.
K213953	BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes	Jul 17, 2023	Substantially Equivalent	Becton, Dickinson and Company
K230080	Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood	Jul 07, 2023	Substantially Equivalent	Yangzhou Medline Industry, Co., Ltd.
K223854	Unistik® ShieldLock, Unistik VacuFlip	Jun 30, 2023	Substantially Equivalent	Owen Mumford, Ltd.
K230408	K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)	Jun 01, 2023	Substantially Equivalent	Sb-Kawasumi Laboratories, Inc.
K220677	Kurin Blood Culture Collection Set with Kurin Lock Technology	Apr 28, 2023	Substantially Equivalent	Kurin, Inc.
K223323	Blood Collection Needle (with/without Needle Holder)	Mar 24, 2023	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
K220212	BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder	Mar 24, 2023	Substantially Equivalent	Becton, Dickinson and Company
K222478	BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device	Mar 10, 2023	Substantially Equivalent	Becton, Dickinson and Company
K223810	Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)	Feb 24, 2023	Substantially Equivalent	Sb-Kawasumi Laboratories, Inc.
K222299	Steripath Micro Blood Collection System	Nov 30, 2022	Substantially Equivalent	Magnolia Medical Technologies
K213690	Eclipse Blood Collection Set	Oct 26, 2022	Substantially Equivalent	Eclipse Medcorp, LLC
K222141	Safety Blood Collection Needle (Without Needle Holder)	Oct 21, 2022	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
K201237	Velano Vascular Blood Collection Adapter	Oct 03, 2022	Substantially Equivalent	Velano Vascular
K213718	SOL-GUARD Safety Pull Button Collection Set	Aug 30, 2022	Substantially Equivalent	Sol-Millennium Medical, Inc.
K220799	K-SHIELD Zen	Aug 29, 2022	Substantially Equivalent	Sb-Kawasumi Laboratories, Inc.
K220900	Safety Blood Collection Needles with/without Needle Holder	Aug 10, 2022	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
K220258	20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)	Jul 14, 2022	Substantially Equivalent	Avia Vascular
K212724	BD Vacutainer UltraTouch Push Button Blood Collection Set	Feb 04, 2022	Substantially Equivalent	Becton, Dickinson and Company
K212019	Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single	Nov 04, 2021	Substantially Equivalent	Jiangsu Micsafe Medical Technology Co., Ltd.
K201009	CHIRAVAC Blood Collection Needles	Jul 21, 2021	Substantially Equivalent	Chirana T. Injecta
K202325	EasyPoint Blood Collection Plus	Apr 09, 2021	Substantially Equivalent	Retractable Technologies, Inc.
K202188	Safety Blood Collection Sets for Single Use	Feb 19, 2021	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
K202446	BD Preset Syringe & BD A-Line Syringe	Sep 25, 2020	Substantially Equivalent	Becton, Dickinson and Company
K200027	Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter	Sep 09, 2020	Substantially Equivalent	Jiangsu Caina Medical Co.,Ltd
K193074	Bevel Up Holder	Apr 21, 2020	Substantially Equivalent	Nsp Tech Pte, Ltd.
K192247	Steripath Gen2 Blood Collection System	Feb 28, 2020	Substantially Equivalent	Magnolia Medical Technologies, Inc.
K191832	Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)	Feb 04, 2020	Substantially Equivalent	Kurin, Inc.
K193569	PIVO(TM)	Jan 21, 2020	Substantially Equivalent	Velano Vascular
K181754	Blood Collection Accessory (BUCA)	Jul 30, 2019	Substantially Equivalent	Nsp Tech Pte, Ltd.
K181743	Blood Transfer Accessory (BTA)	Jul 30, 2019	Substantially Equivalent	Nsp Tech Pte, Ltd.
K190485	Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)	Jul 08, 2019	Substantially Equivalent	Kawasumi Laboratories, Inc.
K190604	PIVO	May 13, 2019	Substantially Equivalent	Velano Vascular
K182078	MiniCollect K2E K2EDTA Tubes	Jan 25, 2019	Substantially Equivalent	Greiner Bio-One Na, Inc.
K181895	Kurin PIV Blood Collection Set with High Pressure	Jan 18, 2019	Substantially Equivalent	Kurin, Inc.
K172763	Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder	Jun 04, 2018	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.
K163073	Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder	May 19, 2017	Substantially Equivalent	Sol-Millennium Medical, Inc.
K163508	PIVO	Feb 09, 2017	Substantially Equivalent	Velano Vascular
K162233	Kurin Blood Culture Collection Set	Dec 23, 2016	Substantially Equivalent	Pathway, LLC
K160657	BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube	Sep 23, 2016	Substantially Equivalent	Becton, Dickinson and Company
K153309	BD Vacutainer UltraTouch Push Button Blood Collection Set	Feb 12, 2016	Substantially Equivalent	Becton, Dickinson and Company
K152924	TIVA¿	Jan 07, 2016	Substantially Equivalent	Velano Vascular
K142946	TIVA	Jan 08, 2015	Substantially Equivalent	Velano Vascular, Inc.
K133303	PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device	Nov 19, 2014	Substantially Equivalent	Bio-Analysis, Inc.
K123987	IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET	Aug 27, 2013	Substantially Equivalent	Innovative Medical Technologies, Inc.
K122355	VANISHPOINT BLOOD COLLECTION SET	Aug 23, 2013	Substantially Equivalent	Retractable Technologies, Inc.
K122687	BLOOD CULTURE HOLDER	Jan 10, 2013	Substantially Equivalent	Greiner Bio-One North America, Inc.
K120490	QUICK SAMPLER HOLDER	Dec 27, 2012	Substantially Equivalent	Nipro Medical Corporation
K103041	VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR	Nov 09, 2010	Substantially Equivalent	Greiner Bio-One North America, Inc.
K093910	IMPROVACUTER GEL & CLOT ACTIVATOR TUBE	Jul 12, 2010	Substantially Equivalent	Guangzhou Improve Medical Instruments Co., Ltd.
K101502	BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774	Jun 29, 2010	Substantially Equivalent	Becton, Dickinson & CO
K093972	BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706	Jan 21, 2010	Substantially Equivalent	Becton, Dickinson & CO
K091292	BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771	Aug 25, 2009	Substantially Equivalent	Becton, Dickinson and Company (BD)
K090737	HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI	Jun 03, 2009	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K081929	VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR	Dec 16, 2008	Substantially Equivalent	Greiner Bio-One North America, Inc.
K081229	SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING	Jul 21, 2008	Substantially Equivalent	Smiths Medical Asd, Inc.
K072783	SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH	Nov 30, 2007	Substantially Equivalent	Smiths Medical Asd, Inc.
K063852	ACCESSA CHOLESTEROL PANEL	Nov 09, 2007	Substantially Equivalent	Home Access Health Corp.
K062932	AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER	Oct 19, 2007	Substantially Equivalent	Ahlstrom Mount Holly Springs, LLC
K063357	MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES	Jul 10, 2007	Substantially Equivalent	Greiner Bio-One North America, Inc.
K061979	MODIFICATION TO MYALLERGY TEST	Sep 22, 2006	Substantially Equivalent	Immunetech Corporation
K060364	VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE	Jun 15, 2006	Substantially Equivalent	Teco Diagnostics
K051019	SAFETY NEEDLE	Jul 25, 2005	Substantially Equivalent	Sarstedt, Inc.
K043143	SAFEPICO	Apr 22, 2005	Substantially Equivalent	Radiometer Medical Aps
K040107	CYTO-CHEX BCT	Jul 27, 2004	Substantially Equivalent	Streck Laboratories, Inc.
K041358	VENOJECT LUER ADAPTER	May 28, 2004	Substantially Equivalent	Terumo Europe N.V.
K041071	BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381	May 14, 2004	Substantially Equivalent	Becton, Dickinson & CO
K030394	FLUID SAMPLE RETRIEVAL SYSTEM	Oct 27, 2003	Substantially Equivalent	Biomed Personal Metabolic and Nutritional Testing
K030815	AKERS LABORATORIES INC. BLOOD CELL SEPARATOR	Sep 17, 2003	Substantially Equivalent	Akers Laboratories, Inc.
K030596	IMMUNICON CELLSAVE PRESERVATIVE TUBE	Aug 08, 2003	Substantially Equivalent	Immunicon Corp.
K030076	PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM	Jul 07, 2003	Substantially Equivalent	Biomed Personal Metabolic and Nutritional Testing
K030573	BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341	May 08, 2003	Substantially Equivalent	Bd Vacutainer Systems Preanalyical Solutions
K023971	VACUETTE TRACE ELEMENTS TUBES	Jan 27, 2003	Substantially Equivalent	Greiner Bio-One Vacuette North America
K023331	BD VACUTAINER SST II PLUS TUBES	Nov 25, 2002	Substantially Equivalent	Becton, Dickinson & CO
K023075	BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE	Nov 25, 2002	Substantially Equivalent	Bd Vacutainer Systems Preanalyical Solutions
K021698	MY ALLERGY TEST	Sep 19, 2002	Substantially Equivalent	Immunetech Corporation
K022875	MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET	Sep 11, 2002	Substantially Equivalent	Becton, Dickinson & CO
K022426	BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538	Aug 08, 2002	Substantially Equivalent	Becton, Dickinson & CO
K022130	BD VACUTAINER PLUS PST II TUBE	Jul 29, 2002	Substantially Equivalent	Becton, Dickinson & CO
K021941	SAMPLOK LUER KIT	Jul 02, 2002	Substantially Equivalent	Itl Corporation Pty, Ltd.
K012221	SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM	Apr 03, 2002	Substantially Equivalent	Biosafe Laboratories, Inc.
K013971	BD VACUTAINER SAFETY COAGULATION TUBE	Feb 01, 2002	Substantially Equivalent	Becton, Dickinson & CO
K011699	VACUETTE EVACUATED BLOOD COLLECTION TUBES	Jun 28, 2001	Substantially Equivalent	Greiner Bio-One Vacuette North America
K002456	MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992	Nov 02, 2000	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K002777	VACUETTE WITH PPACK	Oct 05, 2000	Substantially Equivalent	Greiner Vacuette North America, Inc.
K993787	APPRAISE-CARDIO SAMPLE COLLECTION KIT	Apr 14, 2000	Substantially Equivalent	Osborn Group, Inc.
K000777	SAMPLOK	Apr 11, 2000	Substantially Equivalent	Itl Corporation Pty, Ltd.
K991551	VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE	Sep 23, 1999	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K991702	MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578	Jul 28, 1999	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K992244	GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE	Jul 26, 1999	Substantially Equivalent	Greiner Meditech, Inc.
K991843	GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE	Jun 25, 1999	Substantially Equivalent	Greiner Meditech, Inc.
K991088	VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE	May 28, 1999	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K991120	VACUTAINER BRAND CTAD TUBE (MULTIPLE)	May 19, 1999	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K983952	GREINER VACUETTE BLOOD COLLECTION TUBE	Dec 28, 1998	Substantially Equivalent	Greiner Meditech, Inc.
K983490	TERUMO VENOJECT,LUER ADAPTER	Nov 30, 1998	Substantially Equivalent	Terumo Corp.
K983517	SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM	Nov 12, 1998	Substantially Equivalent	Ram Scientific
K982998	GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE	Oct 21, 1998	Substantially Equivalent	Greiner Meditech, Inc.
K982999	GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE	Oct 16, 1998	Substantially Equivalent	Greiner Meditech, Inc.
K982922	VACUTAINER BRAND BLOOD COLLECTION SYRINGE	Sep 22, 1998	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K981973	SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM	Sep 03, 1998	Substantially Equivalent	Ram Scientific
K981013	VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE	Jun 17, 1998	Substantially Equivalent for Some Indications	Becton Dickinson Vacutainer Systems
K981035	PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES	Apr 21, 1998	Substantially Equivalent	Sims Portex, Inc.
K980414	VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET	Mar 03, 1998	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K980098	VACUTAINER BRAND PRONTO NEEDLES HOLDER	Feb 05, 1998	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K974873	VACUETTE (MULTI-USE HOLDER)	Feb 05, 1998	Substantially Equivalent	Greiner Meditech, Inc.
K974374	SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV	Jan 02, 1998	Substantially Equivalent	Ohmeda Medical
K971111	TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER	Jun 16, 1997	Substantially Equivalent	Tri-Tech, Inc.
K971220	GREINER VACUETTE BLOOD COLLECTION TUBE	Jun 04, 1997	Substantially Equivalent	Greiner America, Inc.
K971239	GREINER VACUETTE BLOOD COLLECTION TUBE	May 12, 1997	Substantially Equivalent	Greiner America, Inc.
K971236	GREINER VACUETTE BLOOD COLLECTION TUBE	May 12, 1997	Substantially Equivalent	Greiner America, Inc.
K964698	SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT	Mar 03, 1997	Substantially Equivalent	Andwin Scientific
K965202	VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET	Feb 10, 1997	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K962158	PICO MODELS 30, 50, 70	Oct 29, 1996	Substantially Equivalent	Radiometer America, Inc.
K962931	SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT	Oct 21, 1996	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K960860	GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3	Sep 05, 1996	Substantially Equivalent	Greiner America, Inc.
K960858	GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR	Aug 30, 1996	Substantially Equivalent	Greiner America, Inc.
K960857	GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR	Aug 30, 1996	Substantially Equivalent	Greiner America, Inc.
K960250	VACUTAINER BRAND PLUS SERUM & SST TUBES	Mar 29, 1996	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K936240	SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)	Mar 19, 1996	Substantially Equivalent	Sudormed, Inc.
K954592	VACUTAINER BRAND PST PLASMA SEPARATION TUBE	Nov 28, 1995	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K953994	SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM	Sep 26, 1995	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K953463	VACUTAINER PLUS TUBES	Sep 20, 1995	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K952516	PRO-VENT, LINE DRAW, PULSATOR	Jul 14, 1995	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K935588	SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION	Jul 14, 1995	Substantially Equivalent	Sudormed, Inc.
K935564	SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION	Jul 14, 1995	Substantially Equivalent	Sudormed, Inc.
K926253	SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE	Jul 14, 1995	Substantially Equivalent	Sudormed, Inc.
K944083	MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE	May 26, 1995	Substantially Equivalent	Sherwood Medical Co.
K944618	NEONATAL BLOOD COLLECTION AND SCREENING FORM	May 10, 1995	Substantially Equivalent	General Business Forms, Inc.
K950432	VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER	May 05, 1995	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K945454	LEUR TIP CAP, VLT CAP(TM)	Apr 14, 1995	Substantially Equivalent	Martell Medical Products, Inc.
K945245	BLOOD KIT, SEXUAL ASSAULT KIT	Feb 01, 1995	Substantially Equivalent	Lynn Peavey Co.
K945952	VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE	Jan 18, 1995	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K945777	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	Dec 22, 1994	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K945353	CLARIT(TM)	Dec 09, 1994	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K944566	VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE	Nov 10, 1994	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K942241	DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN	Aug 18, 1994	Substantially Equivalent	Dupont Medical Products
K942240	DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN	Aug 17, 1994	Substantially Equivalent	Dupont Medical Products
K940905	MICROTAINER BRAND TUBE WITH EDTA(K2)	Aug 02, 1994	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K941159	DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G	May 19, 1994	Substantially Equivalent	International Technidyne Corp.
K922343	TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT	Feb 17, 1994	Unknown	Tri-Tech, Inc.
K933401	THE BUCK	Feb 10, 1994	Substantially Equivalent	Medical Implements, Inc.
K935081	DIRECTDRAW SUPERSERUM-MINI	Jan 11, 1994	Substantially Equivalent	International Technidyne Corp.
K931368	MICROTAINER BRAND TUBE WITH EDTA	Sep 28, 1993	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K922342	TRI-TECH INC. CUSTOM BLOOD ALCOHOL	Aug 27, 1993	Unknown	Tri-Tech, Inc.
K931924	MARKSMAN ARTERIAL BLOOD GAS SYRINGE	Aug 03, 1993	Substantially Equivalent	Martech Medical Products, Inc.
K931367	VACUTAINER BRAND LUER ADAPTER	May 11, 1993	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K924364	VACUPLUS TUBES WITH GREY STOPPERS	Mar 01, 1993	Substantially Equivalent	Starplex Scientific, Inc.
K924362	VACUPLUS TUBES WITH LAVANDER STOPPERS	Mar 01, 1993	Substantially Equivalent	Starplex Scientific, Inc.
K924361	VACUPLUS TUBES WITH GREEN STOPPERS	Mar 01, 1993	Substantially Equivalent	Starplex Scientific, Inc.
K924363	VACUPLUS(R) STAR-SEP(TM)	Feb 08, 1993	Substantially Equivalent	Starplex Scientific, Inc.
K924365	VACUPLUS TUBES WITH BRICK RED STOPPERS	Dec 28, 1992	Substantially Equivalent	Starplex Scientific, Inc.
K923090	SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD	Sep 01, 1992	Substantially Equivalent	Ryan Medical, Inc.
K922445	VACU-PRO	Aug 12, 1992	Substantially Equivalent	Concord/Portex
K921520	VACUTAINER BRAND LUER ADAPTER	Jul 10, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K921806	VACUTAINER(R) BRAND SST(R) AND CAT TUBES	Apr 29, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K915814	SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS	Mar 27, 1992	Unknown	Sirchie Finger Print Laboratories, Inc.
K913399	QBC E-Z PREP	Oct 18, 1991	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K910970	MARKSMAN ARTERIAL BLOOD GAS SYRINGE	Oct 15, 1991	Substantially Equivalent	Martech Medical Products, Inc.
K914129	DIFF SAFE	Oct 11, 1991	Substantially Equivalent	Marshall Levinson
K911809	NEW-VENT	Aug 26, 1991	Substantially Equivalent	Concord/Portex
K911638	SYRINGE TIP CAP	Jun 21, 1991	Substantially Equivalent	Concord/Portex
K910646	SUPERSERUM REAGENT (SSR)	May 10, 1991	Substantially Equivalent	International Technidyne Corp.
K902442	SUDORMED SWEAT PATCH SPECIMEN CONTAINER	Oct 04, 1990	Substantially Equivalent	Sudormed, Inc.
K900856	VEN-O-VAC BLOOD COLLECTION VACUUM TUBES	Sep 21, 1990	Substantially Equivalent	Artefactos DE Vidrio S.A. DE C.V.
K901756	INTERJECTOR BLOOD COLLECTION DEVICE	Aug 29, 1990	Substantially Equivalent	Bowman/Vector, Inc.
K901449	VACUTAINER PLUS WITH HEMOGARD CLOSURE	Aug 09, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K902709	SECUTAINER	Jul 27, 1990	Substantially Equivalent	Preserve
K900726	MICROTEK MEDICAL'S BLOOD COLLECTION KIT	May 04, 1990	Substantially Equivalent	Microbio-Medics, Inc.
K900309	VENOJECT II BLOOD COLLECTION TUBES	Mar 15, 1990	Substantially Equivalent	Terumo Medical Corp.
K896206	STATSPIN STATSAMPLER	Nov 22, 1989	Substantially Equivalent	Statspin Technologies
K892665	PRO-JECT(TM) SAFETY NEEDLE HOLDER	Oct 04, 1989	Substantially Equivalent	Pro-Tec Containers, Inc.
K884970	PINSET	Sep 07, 1989	Substantially Equivalent	Safety Diagnostics, Inc.
K893613	STATSPIN MINI-PLASMA	Aug 28, 1989	Substantially Equivalent	Statspin Technologies
K890109	SAFEPETTE DISPENSER	Feb 23, 1989	Substantially Equivalent	Safe-Tec Clinical Products, Inc.
K884807	LIPOCLEAR LIPEMIA CLEARING REAGENT	Jan 27, 1989	Substantially Equivalent	Statspin Technologies
K884111	PUMPETTE(TM)	Dec 14, 1988	Substantially Equivalent	Helena Laboratories
K883813	CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE	Nov 10, 1988	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K883320	MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE	Sep 27, 1988	Substantially Equivalent	Sherwood Medical Co.
K882614	MONOJECT(R) SNAP-OVER SAFETY CAP	Aug 09, 1988	Substantially Equivalent	Sherwood Medical Co.
K882539	CLEANTECH SYSTEM	Aug 08, 1988	Substantially Equivalent	Schiff & Co.
K881201	HR VACUTRAC	May 16, 1988	Substantially Equivalent	Icu Medical, Inc.
K880594	VACUGUARD(TM)	Apr 28, 1988	Substantially Equivalent	Habley Medical Technology Corp.
K880622	LABCO LIMITED EXETAINER(R)	Apr 18, 1988	Substantially Equivalent	Labco, Ltd.
K864866	RESUBMISSION OF THE KLEERZIT REAGENT	Mar 16, 1987	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K864863	DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)	Jan 13, 1987	Substantially Equivalent	Dynatech Laboratories, Inc.
K863976	OCEAN SCIENTIFIC VACUTEST	Oct 24, 1986	Substantially Equivalent	Ocean Scientific, Inc.
K863491	BLOOD SPECIMEN COLLECTION DEVICES	Oct 24, 1986	Substantially Equivalent	Medelec Intl. Corp.
K853152	MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR	Aug 23, 1985	Substantially Equivalent	Sherwood Medical Co.
K851506	SERUM TRANSPORT VIALS, T25/SC, TZ10/SC	Jun 27, 1985	Substantially Equivalent	Ncs Diagnostics, Inc.
K840496	ISOSTAT MICROBIAL TUBE PROCESSING	Apr 13, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K833475	CAPIJECT SYS CAPILLARY BLOOD COLLECT	Dec 08, 1983	Substantially Equivalent	Terumo Medical Corp.
K833312	ARTERIAL MICRO COLLECTION KIT	Dec 08, 1983	Substantially Equivalent	Current Technologies, Inc.
K831719	MONOJET SPS BLOOD COLLECTION TUBE	Jul 18, 1983	Substantially Equivalent	Sherwood Medical Co.
K830472	LIPOSOL	Jun 08, 1983	Substantially Equivalent	Quest Medical, Inc.
K831242	LITHIUM HEPARINIZED BLOOD COLLECT-TUBE	May 16, 1983	Substantially Equivalent	American Dade
K831081	EZEE FILTER/SEPARATOR	May 16, 1983	Substantially Equivalent	The Kendall Company Div. of Tyco Healthcare Group
K823836	MONOJECT SAMPLETTE CAPILLARY BLOOD COLL	Jan 21, 1983	Substantially Equivalent	Sherwood Medical Co.
K823176	MONOJECT SAMPLETTE CAPILLARY SERUM SEP	Nov 22, 1982	Substantially Equivalent	Sherwood Medical Co.
K822508	MINISAMPLER TM	Oct 22, 1982	Substantially Equivalent	Bms, Inc.
K820717	MONOJECT CORVAC STAT VAC TUBE W/THROM	Apr 01, 1982	Substantially Equivalent	Sherwood Medical Co.
K812285	MONOJECT STERILE CORVAC BLOOD TUBE	Aug 31, 1981	Substantially Equivalent	Sherwood Medical Co.
K811036	FILTER SAMPLER BLOOD SERUM FILTER	Apr 29, 1981	Substantially Equivalent	Glasrock Plastics, Inc.
K810816	PREFILLED ARTERIAL BLOOD SAMPLING SYRING	Apr 07, 1981	Substantially Equivalent	Current Technologies, Inc.
K810664	ISOLATOR SYSTEM	Mar 31, 1981	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K802211	SERUM SEPARATOR	Oct 23, 1980	Substantially Equivalent	Scientific Specialties, Inc.
K802209	SURETY COLUMN	Oct 23, 1980	Substantially Equivalent	Scientific Specialties, Inc.
K792723	BLOOD FLUID FILTERS	Jan 21, 1980	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K792587	VENOJECT AUTOSEP	Jan 17, 1980	Substantially Equivalent	Kimble-Terumo, Inc.
K791303	DORN BLOOD CULTURE COLLECTION TUBE	Sep 17, 1979	Substantially Equivalent	Wadley Institutes of Molecular Medici
K790485	AMYLOCHROME STAT SEPARATOR, TEST	May 03, 1979	Substantially Equivalent	Hoffmann-La Roche, Inc.
K781629	SERI-SEP SERUM/PLASMA ISLOLATOR	Oct 27, 1978	Substantially Equivalent	Wako Intl., Inc.
K770107	SERI-SEP	Mar 22, 1977	Substantially Equivalent	Torval Corp.