FDA product code JSF: Culture Media, Single Biochemical Test
JSF is the FDA product code for culture media, single biochemical test. It is a Class I device, regulated under 21 CFR 866.2320 and reviewed by the Microbiology panel. FDA has cleared 87 510(k) submissions under JSF, from 27 different applicants. The average 510(k) review took 40 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Single Biochemical Test |
| Device class | Class I |
| Regulation | 21 CFR 866.2320 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Top JSF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hardy Media | 20 | 1988-03-31 |
| Irvine Diagnostic Services | 10 | 1984-08-07 |
| bioMerieux, Inc. | 7 | 1985-01-16 |
| Granite Diagnostics, Inc. | 7 | 1982-11-16 |
| Otisville Biotech, Inc. | 4 | 1986-07-03 |
22 more applicants have JSF clearances. See the full list in Caduvo.
Most recent JSF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880946 | Lakewood Biochemical Co., Inc. | NUTRIENT GELATIN - PRODUCT NUMBER T2860 | 1988-04-01 | 25 |
| K880120 | Hardy Media | MOELLERS DECARBOXYLASE, LYSINE | 1988-03-31 | 85 |
| K880126 | Hardy Media | LAURYL TRYPTOSE BROTH | 1988-03-31 | 85 |
| K880119 | Hardy Media | MOELLERS DECARBOXYLASE, ONITHINE | 1988-03-31 | 85 |
| K880135 | Hardy Media | NITRATE BROTH | 1988-03-30 | 84 |
Recalls for JSF devices
openFDA lists no recalls for product code JSF.
Frequently asked questions
What is FDA product code JSF?
JSF is the FDA product code for culture media, single biochemical test. It is a Class I device, regulated under 21 CFR 866.2320 and reviewed by the Microbiology panel.
What device class is JSF?
Class I, regulation 21 CFR 866.2320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSF?
Across 87 cleared submissions the average was 40 days from receipt to decision (median 35).
Which companies have the most JSF clearances?
Hardy Media (20); Irvine Diagnostic Services (10); bioMerieux, Inc. (7); Granite Diagnostics, Inc. (7); Otisville Biotech, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code JSF
- Run a recall and safety report across every JSF manufacturer
- Watch product code JSF 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.