FDA product code JSJ: Culture Media, Selective And Non-Differential
JSJ is the FDA product code for culture media, selective and non-differential. It is a Class I device, regulated under 21 CFR 866.2360 and reviewed by the Microbiology panel. FDA has cleared 307 510(k) submissions under JSJ, from 44 different applicants. The average 510(k) review took 34 days (median 27). FDA has posted 6 recalls for JSJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Selective And Non-Differential |
| Device class | Class I |
| Regulation | 21 CFR 866.2360 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JSJ clearance
Top JSJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lakewood Biochemical Co., Inc. | 30 | 1988-06-22 |
| Acumedia Manufacturers, Inc. | 30 | 1988-04-18 |
| Hardy Media | 26 | 1988-03-31 |
| Otisville Biotech, Inc. | 23 | 1986-07-03 |
| bioMerieux, Inc. | 18 | 1987-04-03 |
39 more applicants have JSJ clearances. See the full list in Caduvo.
Most recent JSJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K882463 | Lakewood Biochemical Co., Inc. | POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 | 1988-06-22 | 7 |
| K881524 | Acumedia Manufacturers, Inc. | DERMATOPHYTE TEST MEDIUM | 1988-04-18 | 10 |
| K881574 | Acumedia Manufacturers, Inc. | W-L DIFFERENTIAL MEDIUM | 1988-04-18 | 7 |
| K881547 | Acumedia Manufacturers, Inc. | MITIS SALIVARIUS AGAR | 1988-04-18 | 10 |
| K881526 | Acumedia Manufacturers, Inc. | CHAPMAN STONE MEDIUM | 1988-04-18 | 10 |
Recalls for JSJ devices
6 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-02-05.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code JSJ?
JSJ is the FDA product code for culture media, selective and non-differential. It is a Class I device, regulated under 21 CFR 866.2360 and reviewed by the Microbiology panel.
What device class is JSJ?
Class I, regulation 21 CFR 866.2360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSJ?
Across 307 cleared submissions the average was 34 days from receipt to decision (median 27).
Which companies have the most JSJ clearances?
Lakewood Biochemical Co., Inc. (30); Acumedia Manufacturers, Inc. (30); Hardy Media (26); Otisville Biotech, Inc. (23); bioMerieux, Inc. (18).
Have JSJ devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2026-02-05.
Next steps
- Run an FDA pathway report with predicate devices for product code JSJ
- Run a recall and safety report across every JSJ manufacturer
- Watch product code JSJ 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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