FDA product code JSA: Culture Media, Antibiotic Assay
JSA is the FDA product code for culture media, antibiotic assay. It is a Class I device, regulated under 21 CFR 866.2350 and reviewed by the Microbiology panel. FDA has cleared 8 510(k) submissions under JSA. The average 510(k) review took 22 days (median 10).
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Antibiotic Assay |
| Device class | Class I |
| Regulation | 21 CFR 866.2350 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JSA clearance
Top JSA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acumedia Manufacturers, Inc. | 8 | 1988-04-18 |
Most recent JSA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881534 | Acumedia Manufacturers, Inc. | ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR | 1988-04-18 | 10 |
| K881536 | Acumedia Manufacturers, Inc. | ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR | 1988-04-18 | 10 |
| K881535 | Acumedia Manufacturers, Inc. | ANTIBIOTIC MEDIUM #6 | 1988-04-18 | 10 |
| K881537 | Acumedia Manufacturers, Inc. | ANTIBIOTIC MEDIUM #19 | 1988-04-18 | 10 |
| K881538 | Acumedia Manufacturers, Inc. | ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR | 1988-04-18 | 10 |
Recalls for JSA devices
openFDA lists no recalls for product code JSA.
Frequently asked questions
What is FDA product code JSA?
JSA is the FDA product code for culture media, antibiotic assay. It is a Class I device, regulated under 21 CFR 866.2350 and reviewed by the Microbiology panel.
What device class is JSA?
Class I, regulation 21 CFR 866.2350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSA?
Across 8 cleared submissions the average was 22 days from receipt to decision (median 10).
Which companies have the most JSA clearances?
Acumedia Manufacturers, Inc. (8).
Next steps
- Run an FDA pathway report with predicate devices for product code JSA
- Run a recall and safety report across every JSA manufacturer
- Watch product code JSA 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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