Culture Media, Anaerobic Transport
The Culture Media, Anaerobic Transport is a microbiology diagnostic transport medium designed to maintain the viability of obligate and facultative anaerobic microorganisms in clinical specimens during transport from the collection site to the laboratory, preserving organisms that would otherwise be inactivated by oxygen exposure before culture can be initiated. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JSL and is regulated under 21 CFR 866.2390, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- JSL
- Device Class
- FDA class 1
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972449 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | Aug 20, 1997 | Substantially Equivalent | COPAN ITALIA SPA |
| K972448 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | Aug 20, 1997 | Substantially Equivalent | COPAN ITALIA SPA |
| K944847 | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | Feb 16, 1995 | Substantially Equivalent | STARPLEX SCIENTIFIC, INC. |
| K925450 | BIONOR TRANSPORTMEDIUM | Jun 25, 1993 | Substantially Equivalent | SKOUG RESEARCH CORP. |
| K841220 | ANAEROBIC TRANSPORT MEDIUM | Apr 04, 1984 | Substantially Equivalent | ANAEROBE SYSTEMS |
| K834357 | ANA TRANS TUBE & SWABS STERILE PACK | Jan 31, 1984 | Substantially Equivalent | ANAEROBE SYSTEMS |
| K770840 | PRE-REDUCED ANAEROBIC MEDIA | Jun 08, 1977 | Substantially Equivalent | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
| K770650 | PRE-DUCED CULTURE MEDIA | Apr 15, 1977 | Substantially Equivalent | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.