Product Code: JTW FDA class 1 21 CFR 866.2900

System, Transport, Aerobic

Microbiology

System, Transport, Aerobic is a specimen transport system designed to maintain the viability of aerobic microorganisms in clinical specimens from the time of collection until laboratory processing, preserving organism integrity for subsequent culture and identification. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JTW, regulated under 21 CFR 866.2900, and falls within the Microbiology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: JTW
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 43 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K121039	COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM	May 25, 2012	Substantially Equivalent	Copan Flock Technologies
K061301	COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM	Jun 23, 2006	Substantially Equivalent	Copan Diagnostics, Inc.
K022874	GEN-PROBE APTIMA COMBO 2 ASSAY	Sep 17, 2002	Substantially Equivalent	Gen-Probe, Inc.
K013819	URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM	Feb 28, 2002	Substantially Equivalent	Sierra Diagnostic, LLC
K993161	COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM	Nov 09, 1999	Substantially Equivalent	Copan Diagnostics, Inc.
K983244	SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)	Nov 30, 1998	Substantially Equivalent	Trek Diagnostic Systems, Inc.
K961148	CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)	Apr 26, 1996	Substantially Equivalent	Difco Laboratories, Inc.
K934894	CULTURESWAB TRANSPORT SYSTEM	Feb 22, 1994	Substantially Equivalent	Difco Laboratories, Inc.
K904773	P AND T MEDIUM	Dec 04, 1990	Substantially Equivalent	Gibson Laboratories, Inc.
K895187	FDL, INC.'S TRANSPORT SYSTEM	Oct 24, 1989	Substantially Equivalent	Fairleigh Dickinson Laboratories, Inc.
K882580	MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE	Jul 08, 1988	Substantially Equivalent	Precision Dynamics Corp.
K872325	GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT	Aug 12, 1987	Substantially Equivalent	Technology Management & Marketing, Inc.
K872326	GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT	Aug 11, 1987	Substantially Equivalent	Technology Management & Marketing, Inc.
K843359	URINE TRANSPORT KIT	Sep 27, 1984	Substantially Equivalent	Applied Polytechnology, Inc.
K843341	GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK	Sep 27, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K843173	CELL-MATICS VIRAL TRANSPORT PACK	Sep 06, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K840719	BAKTERIETTE-VI-PAK	Apr 04, 1984	Substantially Equivalent	Great Lakes Intl.
K840991	PRESERV BUFFERED GLYCEROL SALINE	Mar 23, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K840990	PRESERV CARY BLAIR TRANSPORT PACK	Mar 23, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K840968	PRESERV TRANSPORT & CULTURE PACK	Mar 23, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K831579	GONORRHEA TRANSETTE 1 & 3	Jun 17, 1983	Substantially Equivalent	Spectrum Diagnostic, Inc.
K830250	CVT VIRAL TRANSPORTS	Feb 28, 1983	Substantially Equivalent	Immulok, Inc.
K823443	HERPES TRANSETTE	Dec 03, 1982	Substantially Equivalent	Spectrum Diagnostic, Inc.
K811284	GC TTANSPORT SYSTEM	Jun 12, 1981	Substantially Equivalent	Biolog, Inc.
K811283	JEMBEC TRANSPORT SYSTEM	Jun 12, 1981	Substantially Equivalent	Biolog, Inc.
K803298	MINI-TIP CULTURETTE	Jan 12, 1981	Substantially Equivalent	Marion Laboratories, Inc.
K802563	TRANSETTE SYSTEM/COLLECTION & TRANSP	Oct 31, 1980	Substantially Equivalent	Inolex Corp./Div of Biomedical
K802023	CULSWAB CAT.#978 & 979	Sep 09, 1980	Substantially Equivalent	Pollak (Intl.), Ltd.
K791953	PDC 304 DOUBLE SWAB CULTURE COLLECTION	Oct 30, 1979	Substantially Equivalent	Precision Dynamics Corp.
K791924	PDC 104 SINGLE SWAB CULTURE COLLECTION	Oct 17, 1979	Substantially Equivalent	Precision Dynamics Corp.
K790366	URINE CULTURE KIT	Apr 04, 1979	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K780440	CHAMBER, AEROBIC	Apr 10, 1978	Substantially Equivalent	Marion Laboratories, Inc.
K772209	CULTURE COLLEC. TRANS. SYS., DOUBLE DRY	Dec 20, 1977	Substantially Equivalent	Precision Dynamics Corp.
K772207	CULTURE COLLEC. TRANS. SYS., SINGLE WET	Dec 20, 1977	Substantially Equivalent	Precision Dynamics Corp.
K772210	CULTURE COLLEC. TRANS. SYS., DOUBLE WET	Dec 09, 1977	Substantially Equivalent	Precision Dynamics Corp.
K772208	CULTURE COLLEC. TRANS. SYS., SINGLE DRY	Dec 09, 1977	Substantially Equivalent	Precision Dynamics Corp.
K772206	CULTURE COLLEC. TRANS. SYS., SINGLE WET	Dec 09, 1977	Substantially Equivalent	Precision Dynamics Corp.
K772205	CULTURE COLLEC. TRANS. SYS., DOUBLE WET	Dec 09, 1977	Substantially Equivalent	Precision Dynamics Corp.
K771058	EPTONE BACK-UP BROTH, VACUTAINER	Jul 01, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K770957	PEDIATRIC BLOOD CULTURE BOTTLES	Jun 14, 1977	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K770683	BOTTLE, BLOOD CULTURE, BI-PHASIC	Apr 26, 1977	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K760458	BOTTLE, BLOOD CULTURE, SCHAEDLER	Sep 03, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K760054	CULTURE TUBE, (VACUTAINER)	Aug 03, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic