FDA product code JSK: Supplement, Culture Media
JSK is the FDA product code for supplement, culture media. It is a Class I device, regulated under 21 CFR 866.2450 and reviewed by the Microbiology panel. FDA has cleared 70 510(k) submissions under JSK, from 16 different applicants. The average 510(k) review took 38 days (median 35). FDA has posted 6 recalls for JSK devices.
Classification
| Field | Value |
|---|---|
| Device name | Supplement, Culture Media |
| Device class | Class I |
| Regulation | 21 CFR 866.2450 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JSK clearance
Top JSK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oxoid U.S.A., Inc. | 30 | 1984-05-11 |
| Acumedia Manufacturers, Inc. | 10 | 1988-04-18 |
| Pro-Lab, Inc. | 7 | 1985-03-22 |
| Gibco Laboratories Life Technologies, Inc. | 7 | 1983-10-14 |
| Flow Laboratories, Inc. | 3 | 1986-05-20 |
11 more applicants have JSK clearances. See the full list in Caduvo.
Most recent JSK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881949 | Alpha-Tec Systems, Inc. | ATS NAC-PAC SET | 1988-05-25 | 15 |
| K881879 | Alpha-Tec Systems, Inc. | ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 | 1988-05-13 | 9 |
| K881566 | Acumedia Manufacturers, Inc. | HEMOGLOBIN POWDER | 1988-04-18 | 7 |
| K861997 | Hazleton Research Products, Inc. | PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE | 1986-06-10 | 18 |
| K861824 | Flow Laboratories, Inc. | GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) | 1986-05-20 | 8 |
Recalls for JSK devices
6 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-09-11.
Frequently asked questions
What is FDA product code JSK?
JSK is the FDA product code for supplement, culture media. It is a Class I device, regulated under 21 CFR 866.2450 and reviewed by the Microbiology panel.
What device class is JSK?
Class I, regulation 21 CFR 866.2450. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSK?
Across 70 cleared submissions the average was 38 days from receipt to decision (median 35).
Which companies have the most JSK clearances?
Oxoid U.S.A., Inc. (30); Acumedia Manufacturers, Inc. (10); Pro-Lab, Inc. (7); Gibco Laboratories Life Technologies, Inc. (7); Flow Laboratories, Inc. (3).
Have JSK devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2015-09-11.
Next steps
- Run an FDA pathway report with predicate devices for product code JSK
- Run a recall and safety report across every JSK manufacturer
- Watch product code JSK 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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