FDA product code JSL: Culture Media, Anaerobic Transport
JSL is the FDA product code for culture media, anaerobic transport. It is a Class I device, regulated under 21 CFR 866.2390 and reviewed by the Microbiology panel. FDA has cleared 8 510(k) submissions under JSL, from 5 different applicants. The average 510(k) review took 73 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Anaerobic Transport |
| Device class | Class I |
| Regulation | 21 CFR 866.2390 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JSL clearance
Top JSL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Copan Italia Spa | 2 | 1997-08-20 |
| Anaerobe Systems | 2 | 1984-04-04 |
| Gibco Laboratories Life Technologies, Inc. | 2 | 1977-06-08 |
| Starplex Scientific, Inc. | 1 | 1995-02-16 |
| Skoug Research Corp. | 1 | 1993-06-25 |
Most recent JSL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972448 | Copan Italia Spa | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | 1997-08-20 | 51 |
| K972449 | Copan Italia Spa | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | 1997-08-20 | 51 |
| K944847 | Starplex Scientific, Inc. | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | 1995-02-16 | 139 |
| K925450 | Skoug Research Corp. | BIONOR TRANSPORTMEDIUM | 1993-06-25 | 240 |
| K841220 | Anaerobe Systems | ANAEROBIC TRANSPORT MEDIUM | 1984-04-04 | 13 |
Recalls for JSL devices
openFDA lists no recalls for product code JSL.
Frequently asked questions
What is FDA product code JSL?
JSL is the FDA product code for culture media, anaerobic transport. It is a Class I device, regulated under 21 CFR 866.2390 and reviewed by the Microbiology panel.
What device class is JSL?
Class I, regulation 21 CFR 866.2390. Typical premarket route: 510(k).
How long does a 510(k) take for product code JSL?
Across 8 cleared submissions the average was 73 days from receipt to decision (median 50).
Which companies have the most JSL clearances?
Copan Italia Spa (2); Anaerobe Systems (2); Gibco Laboratories Life Technologies, Inc. (2); Starplex Scientific, Inc. (1); Skoug Research Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JSL
- Run a recall and safety report across every JSL manufacturer
- Watch product code JSL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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