FDA product code JSE: Culture Media, Multiple Biochemical Test
JSE is the FDA product code for culture media, multiple biochemical test. It is a Class I device, regulated under 21 CFR 866.2320 and reviewed by the Microbiology panel. FDA has cleared 53 510(k) submissions under JSE, from 24 different applicants. The average 510(k) review took 29 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Multiple Biochemical Test |
| Device class | Class I |
| Regulation | 21 CFR 866.2320 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JSE clearance
Top JSE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hardy Media | 7 | 1988-03-31 |
| Otisville Biotech, Inc. | 7 | 1986-07-03 |
| Analytical Products, Inc. | 5 | 1985-03-29 |
| Micro Media Laboratories | 5 | 1983-12-22 |
| Isle Media and Sterile Products, Inc. | 3 | 1979-12-31 |
19 more applicants have JSE clearances. See the full list in Caduvo.
Most recent JSE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962265 | Dynatech Laboratories, Inc. | MLX MICROTITER PLATE LUMINOMETER | 1996-07-25 | 43 |
| K883995 | Pro-Lab, Inc. | X-ACT UREA/TDA | 1988-10-12 | 22 |
| K883996 | Pro-Lab, Inc. | X-ACT LDC/IND | 1988-10-12 | 22 |
| K880116 | Hardy Media | MRVP BROTH | 1988-03-31 | 85 |
| K880133 | Hardy Media | MIL MEDIUM | 1988-03-31 | 85 |
Recalls for JSE devices
openFDA lists no recalls for product code JSE.
Frequently asked questions
What is FDA product code JSE?
JSE is the FDA product code for culture media, multiple biochemical test. It is a Class I device, regulated under 21 CFR 866.2320 and reviewed by the Microbiology panel.
What device class is JSE?
Class I, regulation 21 CFR 866.2320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSE?
Across 53 cleared submissions the average was 29 days from receipt to decision (median 26).
Which companies have the most JSE clearances?
Hardy Media (7); Otisville Biotech, Inc. (7); Analytical Products, Inc. (5); Micro Media Laboratories (5); Isle Media and Sterile Products, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code JSE
- Run a recall and safety report across every JSE manufacturer
- Watch product code JSE 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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