FDA product code JSC: Culture Media, General Nutrient Broth
JSC is the FDA product code for culture media, general nutrient broth. It is a Class I device, regulated under 21 CFR 866.2350 and reviewed by the Microbiology panel. FDA has cleared 52 510(k) submissions under JSC, from 20 different applicants. The average 510(k) review took 28 days (median 24). FDA has posted 5 recalls for JSC devices.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, General Nutrient Broth |
| 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 JSC clearance
Top JSC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Anaerobe Systems | 6 | 1984-04-04 |
| Acumedia Manufacturers, Inc. | 6 | 1983-11-07 |
| Isle Media and Sterile Products, Inc. | 6 | 1979-09-04 |
| Hardy Media | 5 | 1982-07-08 |
| Abbott Laboratories | 4 | 1980-03-19 |
15 more applicants have JSC clearances. See the full list in Caduvo.
Most recent JSC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K850143 | American Sterilizer Co. | SPORDEX CULTURE MEDIA | 1985-03-05 | 50 |
| K842849 | Anarobe Systems | TRYPTICASE SOY BROTH | 1984-08-03 | 14 |
| K842852 | Anarobe Systems | BRAIN HEART INFUSION BROTH | 1984-08-03 | 14 |
| K841221 | Anaerobe Systems | BRAIN HEART INFUSION BROTH | 1984-04-04 | 13 |
| K841219 | Anaerobe Systems | SHOPPED MEAT CARBOHYDRATE | 1984-04-04 | 13 |
Recalls for JSC devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-09-30.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code JSC?
JSC is the FDA product code for culture media, general nutrient broth. It is a Class I device, regulated under 21 CFR 866.2350 and reviewed by the Microbiology panel.
What device class is JSC?
Class I, regulation 21 CFR 866.2350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSC?
Across 52 cleared submissions the average was 28 days from receipt to decision (median 24).
Which companies have the most JSC clearances?
Anaerobe Systems (6); Acumedia Manufacturers, Inc. (6); Isle Media and Sterile Products, Inc. (6); Hardy Media (5); Abbott Laboratories (4).
Have JSC devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2021-09-30.
Next steps
- Run an FDA pathway report with predicate devices for product code JSC
- Run a recall and safety report across every JSC manufacturer
- Watch product code JSC 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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