Product Code: LIO FDA class 1 21 CFR 866.2900

Device, Specimen Collection

Microbiology

A specimen collection device is a microbiological tool used to collect patient samples such as swabs, aspirates, or other specimens for subsequent laboratory analysis, supporting the diagnostic workup of infectious and other diseases. The device is FDA Class 1, the lowest risk category, requiring only general controls and 510(k) notification in this classification scenario. It carries product code LIO and is regulated under 21 CFR 866.2900 within the Microbiology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LIO
Device Class: FDA class 1
Regulation Number: 866.2900
Medical Specialty: Microbiology
Review Panel: MI
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 63 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K222613	ARX Liquid Amies Collection & Transport System	Mar 27, 2024	Substantially Equivalent	Arx Sciences, Inc.
K131630	PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM	Oct 21, 2013	Substantially Equivalent	Puritan Medical Products, LLC
K120846	TRANSPORT CULTURE MEDIUM DEVICE	Jun 08, 2012	Substantially Equivalent	Puritan Medical Products, LLC
K103805	MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE	Jan 25, 2011	Substantially Equivalent	Medical Wire & Equipment Company (Bath), Ltd.
K082472	VIROCULT, MODEL MW950	Dec 30, 2008	Substantially Equivalent	Medical Wire & Equipment Company (Bath), Ltd.
K070062	COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE	Jul 30, 2007	Substantially Equivalent	Diesse Diagnostica Senese S.P.A.
K013711	BACTI-SWAB DRY	Nov 26, 2001	Substantially Equivalent	Remel Co.
K003761	NAT - NUCLEIC ACID TRANSPORT	May 31, 2001	Substantially Equivalent	Medical Packaging Corp.
K983119	ENTERO-TEST HP, MODEL #102-01	Mar 15, 1999	Substantially Equivalent	Hdc Corp.
K981391	PAR-ONE	Jul 14, 1998	Substantially Equivalent	Remel, Inc.
K964144	PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF	Nov 27, 1996	Substantially Equivalent	Para Scientific Co.
K963986	STP SYSTEM PVA WITH ZINC	Nov 08, 1996	Substantially Equivalent	Sage Products, Inc.
K964026	STP SYSTEM - SAF	Nov 07, 1996	Substantially Equivalent	Sage Products, Inc.
K964027	STP SYSTEM-PVA WITH MERCURY	Nov 01, 1996	Substantially Equivalent	Sage Products, Inc.
K960997	STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM	Apr 03, 1996	Substantially Equivalent	Starplex Scientific, Inc.
K953929	MID-STREAM COLLECTION SET-STERILE	Nov 16, 1995	Substantially Equivalent	Trinity Laboratories, Inc.
K950096	PINWORM EGG COLLECTOR	Apr 05, 1995	Substantially Equivalent	Evergreen Industries, Inc.
K931770	PARA-PAK PLUS	Jun 15, 1993	Substantially Equivalent	Meridian Diagnostics, Inc.
K931383	ZINC PVA	Jun 15, 1993	Substantially Equivalent	Remel Co.
K930313	APEX SPECIMEN BAG	Mar 18, 1993	Substantially Equivalent	Apex Medical Technologies, Inc.
K924053	CYTOQUANT COMBINED TRANSPORT MEDIA	Jan 15, 1993	Substantially Equivalent	Proteins Intl., Inc.
K924331	TRANSYSTEM LIQUID STUART MEDIUM	Dec 24, 1992	Substantially Equivalent	Pro-Lab Diagnostics
K924330	TRANSYSTEM AMIES WITH CHARCOAL	Dec 24, 1992	Substantially Equivalent	Pro-Lab Diagnostics
K924329	TRANSYSTEM AMIES W/O CHARCOAL	Dec 24, 1992	Substantially Equivalent	Pro-Lab Diagnostics
K924328	TRANSYSTEM LIQUID AMIES MEDIUM	Dec 24, 1992	Substantially Equivalent	Pro-Lab Diagnostics
K920536	AFFIRM VP SAMPLE COLLECTION SET	Jul 30, 1992	Substantially Equivalent	Microprobe Corp.
K920761	URINE CULTUR STABILIZATION TRANSPORT TUBE	Jun 19, 1992	Substantially Equivalent	Bio Medicus, Inc.
K915454	CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT	Apr 08, 1992	Substantially Equivalent	Medical Packaging Corp.
K912832	BACTI-SWAB(TM) NPG	Aug 22, 1991	Substantially Equivalent	Remel Co.
K912831	BACTI-SWAB(TM) II	Jul 30, 1991	Substantially Equivalent	Remel Co.
K903638	GASTRO-INTESTINAL ACCU-CULSHURE TM	Jan 18, 1991	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K905120	SAF FIXATIVE	Dec 17, 1990	Substantially Equivalent	Gibson Laboratories, Inc.
K903406	VIRAL ACCU-CULSHURE TM	Oct 16, 1990	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K903405	CHLAMYDIA ACCU-CULSHURE TM	Oct 16, 1990	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K902467	FLORA-STAT URINE TRANSPORT SYSTEM	Aug 22, 1990	Substantially Equivalent	Wadley Biosciences Corp.
K896794	SPECIMEN CONTAINER	Mar 01, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K900225	ROMCHECK SPECIMEN COLLECTION KIT	Feb 02, 1990	Substantially Equivalent	Adeza Biomedical
K893905	PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)	Aug 03, 1989	Substantially Equivalent	Diagnostic Products Corp.
K890134	FTK FECAL TRANSPORT KIT	Apr 21, 1989	Substantially Equivalent	Evergreen Scientific, Inc.
K884342	NOVAPATH SPECIMEN COLLECTION KIT	Nov 03, 1988	Substantially Equivalent	Bio-Rad
K882485	DIVERSI-KIT	Jul 18, 1988	Substantially Equivalent	Intl. Cancer Screening Laboratories, Inc.
K873565	SNAP(R) ROTAVIRUS DIAGNOSTIC KIT	May 13, 1988	Substantially Equivalent	Molecular Biosystems, Inc.
K881125	PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT	Mar 23, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K874456	CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT	Nov 24, 1987	Substantially Equivalent	Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd.
K872751	FLUORTRAN - C(TM)	Jul 23, 1987	Substantially Equivalent	Para Scientific Co.
K871860	NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT	May 29, 1987	Substantially Equivalent	Bio-Rad
K870963	MODIFIED PATHFINDER SPECIMEN COLLECTION KIT	Apr 08, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K870231	KULTSURE	Feb 04, 1987	Substantially Equivalent	Ncs Diagnostics, Inc.
K864727	CULT-UR	Jan 05, 1987	Substantially Equivalent	R.P. Laboratories, Inc.
K862607	IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT	Aug 04, 1986	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K860655	KULTSURE (CATALOGUE NO. M200)	Mar 06, 1986	Substantially Equivalent	Ncs Diagnostics, Inc.
K854719	LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER)	Feb 24, 1986	Substantially Equivalent	Xsirius Scientific, Inc.
K851378	VIRTRAN VIRAL TRANPORTER	Jun 21, 1985	Substantially Equivalent	Diagnon Corp.
K851387	MICROSTATIC URINE TRANSPORT TUBE FOR C & S	May 20, 1985	Substantially Equivalent	Analytical Luminescence Laboratory, Inc.
K843000	MICRO ORGANISM GROWTH SYS-M1000	Feb 06, 1985	Substantially Equivalent	Hml Inc/Biotechnology Transfer
K843935	MODIFICATION MICROTRAK DIRECT SPECIMEN TEST	Oct 23, 1984	Substantially Equivalent	Syva Co.
K840799	V.D.T.-GONORRHEA TEST KIT	Jun 07, 1984	Substantially Equivalent	M.G. Laboratories, Inc.
K833814	SANI CATCH BA	Mar 19, 1984	Substantially Equivalent	Concord Laboratories, Inc.
K834566	PRESERV SAF FIXATIVE 15ML	Feb 04, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K840086	PRESERV MF FIXATIVE 15ML	Jan 30, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K832079	COLLECTION KIT CHLAMYDIA TRACHOMATIS	Sep 29, 1983	Substantially Equivalent	Syva Co.
K832246	DUPONT ISOLATOR 1.5 MICROBIAL TUBE	Sep 26, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K820520	VD ALERT	May 14, 1982	Substantially Equivalent	Intl. Research Distributors, Inc.