FDA product code JSW: Kit, Identification, Glucose Nonfermenter
JSW is the FDA product code for kit, identification, glucose nonfermenter. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under JSW, from 6 different applicants. The average 510(k) review took 50 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Kit, Identification, Glucose Nonfermenter |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JSW clearance
Top JSW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomerieux Vitek, Inc. | 1 | 1992-10-14 |
| Innovative Diagnostic Systems, Inc. | 1 | 1990-03-13 |
| Austin Biological Laboratories | 1 | 1987-04-03 |
| Micro-Palettes, Inc. | 1 | 1979-06-22 |
| Corning Medical & Scientific | 1 | 1977-11-17 |
1 more applicants have JSW clearances. See the full list in Caduvo.
Most recent JSW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K922768 | Biomerieux Vitek, Inc. | RAPID NFT, MODIFICATION | 1992-10-14 | 128 |
| K900517 | Innovative Diagnostic Systems, Inc. | RAPID NF SYSTEM | 1990-03-13 | 39 |
| K870769 | Austin Biological Laboratories | AUSTIN NONFERMENTER KIT | 1987-04-03 | 36 |
| K790992 | Micro-Palettes, Inc. | PSEUDO-PALETTE TM | 1979-06-22 | 24 |
| K772112 | Corning Medical & Scientific | NON-FERMENTER SYSTEM | 1977-11-17 | 10 |
Recalls for JSW devices
openFDA lists no recalls for product code JSW.
Frequently asked questions
What is FDA product code JSW?
JSW is the FDA product code for kit, identification, glucose nonfermenter. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JSW?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSW?
Across 6 cleared submissions the average was 50 days from receipt to decision (median 38).
Which companies have the most JSW clearances?
Biomerieux Vitek, Inc. (1); Innovative Diagnostic Systems, Inc. (1); Austin Biological Laboratories (1); Micro-Palettes, Inc. (1); Corning Medical & Scientific (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JSW
- Run a recall and safety report across every JSW manufacturer
- Watch product code JSW 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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