FDA product code JSH: Culture Media, Non-Selective And Differential
JSH is the FDA product code for culture media, non-selective and differential. It is a Class I device, regulated under 21 CFR 866.2320 and reviewed by the Microbiology panel. FDA has cleared 146 510(k) submissions under JSH, from 35 different applicants. The average 510(k) review took 29 days (median 26). FDA has posted 2 recalls for JSH devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Non-Selective And Differential |
| 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 JSH clearance
Top JSH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acumedia Manufacturers, Inc. | 21 | 1988-04-18 |
| Isle Media and Sterile Products, Inc. | 17 | 1980-04-24 |
| bioMerieux, Inc. | 12 | 1987-04-03 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 10 | 1987-06-02 |
| Otisville Biotech, Inc. | 9 | 1986-07-03 |
30 more applicants have JSH clearances. See the full list in Caduvo.
Most recent JSH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881560 | Acumedia Manufacturers, Inc. | UREA BROTH | 1988-04-18 | 7 |
| K881551 | Acumedia Manufacturers, Inc. | PHENOL RED BROTH BASE | 1988-04-18 | 10 |
| K881540 | Acumedia Manufacturers, Inc. | FLO AGAR | 1988-04-18 | 10 |
| K881486 | Acumedia Manufacturers, Inc. | DNASE TEST AGAR | 1988-04-18 | 10 |
| K881553 | Acumedia Manufacturers, Inc. | RUSSELL DOUBLE SUGAR AGAR | 1988-04-18 | 10 |
Recalls for JSH devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-07-11.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JSH?
JSH is the FDA product code for culture media, non-selective and differential. It is a Class I device, regulated under 21 CFR 866.2320 and reviewed by the Microbiology panel.
What device class is JSH?
Class I, regulation 21 CFR 866.2320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSH?
Across 146 cleared submissions the average was 29 days from receipt to decision (median 26).
Which companies have the most JSH clearances?
Acumedia Manufacturers, Inc. (21); Isle Media and Sterile Products, Inc. (17); bioMerieux, Inc. (12); Bd Becton Dickinson Vacutainer Systems Preanalytic (10); Otisville Biotech, Inc. (9).
Have JSH devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-07-11.
Next steps
- Run an FDA pathway report with predicate devices for product code JSH
- Run a recall and safety report across every JSH manufacturer
- Watch product code JSH 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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