FDA product code JSQ: Chromatography For Bacterial Identification
JSQ is the FDA product code for chromatography for bacterial identification. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under JSQ, from 3 different applicants. The average 510(k) review took 26 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Chromatography For Bacterial Identification |
| Device class | Class I |
| Regulation | 21 CFR 862.2250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JSQ clearance
Top JSQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro Media Laboratories | 1 | 1983-12-22 |
| Acumedia Manufacturers, Inc. | 1 | 1981-05-05 |
| Supelco, Inc. | 1 | 1977-01-14 |
Most recent JSQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K834007 | Micro Media Laboratories | CYSTINE TRYPTIC MEDIUM | 1983-12-22 | 31 |
| K811138 | Acumedia Manufacturers, Inc. | NUTRIENT AGAR | 1981-05-05 | 11 |
| K761226 | Supelco, Inc. | GP3%SP-2100DOHON100/120 MESH SUPELCOPORT | 1977-01-14 | 36 |
Recalls for JSQ devices
openFDA lists no recalls for product code JSQ.
Frequently asked questions
What is FDA product code JSQ?
JSQ is the FDA product code for chromatography for bacterial identification. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel.
What device class is JSQ?
Class I, regulation 21 CFR 862.2250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSQ?
Across 3 cleared submissions the average was 26 days from receipt to decision (median 31).
Which companies have the most JSQ clearances?
Micro Media Laboratories (1); Acumedia Manufacturers, Inc. (1); Supelco, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JSQ
- Run a recall and safety report across every JSQ manufacturer
- Watch product code JSQ 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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