Product Code: GIM FDA class 2 21 CFR 862.1675

Tubes, Vacuum Sample, With Anticoagulant

Clinical Chemistry

Tubes, Vacuum Sample, with Anticoagulant (product code GIM) are evacuated blood collection tubes containing an anticoagulant additive, used to collect and preserve blood specimens for clinical chemistry and other laboratory analyses by preventing clotting during specimen transport and processing. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 862.1675 in the Clinical Chemistry specialty (CH), this device carries no flags for implantation, life support, GMP exemption, or third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: GIM
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

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 39 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240455	BD Vacutainer® Citrate Blood Collection Tubes	Oct 31, 2024	Substantially Equivalent	Becton, Dickinson and Company
K230493	BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube	Nov 27, 2023	Substantially Equivalent	Becton, Dickinson and Company
K213670	BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes	Aug 25, 2023	Substantially Equivalent	Becton, Dickinson and Company
K162723	TransFix/EDTA Vacuum Blood Collection Tubes	Jun 22, 2017	Substantially Equivalent	Caltag Medsystems, Ltd.
K080552	CYTO-CHEX BCT	Jul 31, 2008	Substantially Equivalent	Streck
K012152	DS30 HCY BLOOD COLLECTION TUBES	Sep 18, 2001	Substantially Equivalent	Drew Scientific , Ltd.
K971449	VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)	Jun 17, 1997	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K971221	GREINER VACUETTE BLOOD COLLECTION TUBE	May 02, 1997	Substantially Equivalent	Greiner America, Inc.
K951886	LOK-ON NEEDLE DISPOSAL SYSTEM	Jun 30, 1995	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K945458	VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM	Feb 06, 1995	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K944814	CORVAC PLASTIC BLOOD COLLECTION TUBE	Dec 19, 1994	Substantially Equivalent	Sherwood Medical Co.
K940058	MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER	May 02, 1994	Substantially Equivalent	Sherwood Medical Co.
K933939	BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT	Feb 07, 1994	Substantially Equivalent	Organon Teknika Corp.
K933386	VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM	Oct 12, 1993	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K922858	MULTIDRAW SYSTEM	Nov 16, 1992	Unknown	Cambridge Multi-Draw, Inc.
K922468	ANGEL WING SETS -- MODIFIED	Jul 10, 1992	Substantially Equivalent	Mbo Laboratories, Inc.
K921778	DIRECTDRAW SUPERSERUM	May 28, 1992	Substantially Equivalent	International Technidyne Corp.
K921636	VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET	Apr 29, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K920184	ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.	Feb 18, 1992	Substantially Equivalent	Mbo Laboratories, Inc.
K915213	CORVAC BLOOD COLLECTION TUBE	Jan 08, 1992	Substantially Equivalent	Sherwood Medical Co.
K914901	VACUTAINER KIT	Jan 08, 1992	Substantially Equivalent	Abbott Laboratories
K896373	1400 SERIES EVIDENCE COLLECTION KIT	Feb 26, 1990	Substantially Equivalent	Transidyne General Corp.
K896514	QS90 SMOOTH E ARTERIAL BLOOD SAMPLER	Jan 23, 1990	Substantially Equivalent	Radiometer America, Inc.
K882501	ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100	Jul 18, 1988	Substantially Equivalent	Terumo Medical Corp.
K861449	VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)	Sep 16, 1986	Substantially Equivalent	Exel Intl.
K803182	SYRINGE FOR BLOOD SAMPLING	Jan 16, 1981	Substantially Equivalent	The University of Chicago
K801015	PREZAPAK L ARTERIAL BLOOD SAMPLING KIT	May 14, 1980	Substantially Equivalent	Kimble-Terumo, Inc.
K791200	PRE-DENT	Aug 10, 1979	Substantially Equivalent	Fichte, Graves, and Hunt
K771874	J-VAC VACUUM TUBE	Dec 02, 1977	Substantially Equivalent	Jelco Laboratories
K771985	FILTER SAMPLER BLOOD SERUM FILTER	Nov 02, 1977	Substantially Equivalent	Clasrock
K771305	LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.	Aug 04, 1977	Substantially Equivalent	Organon, Inc.
K771304	LIQUAEMIB SODIUM PRESERVATIVE, ETC.	Aug 04, 1977	Substantially Equivalent	Organon, Inc.
K771056	BLOOD COLLECTION TUBE, GREEN	Jun 29, 1977	Substantially Equivalent	Sherwood Medical Industries
K771055	BLOOD COLLECTION TUBE, RED	Jun 29, 1977	Substantially Equivalent	Sherwood Medical Industries
K771054	BLOOD COLLECTION TUBE, BLUE	Jun 29, 1977	Substantially Equivalent	Sherwood Medical Industries
K771053	BLOOD COLLECTION TUBE, GRAY	Jun 29, 1977	Substantially Equivalent	Sherwood Medical Industries
K771052	BLOOD COLLECTION TUBE, LAVENDER	Jun 27, 1977	Substantially Equivalent	Sherwood Medical Industries
K760019	VACUUM TUBES, PEDIATRIC SIZES (J-VAC)	Jul 20, 1976	Substantially Equivalent	Jelco Laboratories
K760018	VACUUM TUBES, STERILE (J-VAC)	Jul 20, 1976	Substantially Equivalent	Jelco Laboratories