FDA product code JSG: Culture Media, Non-Selective And Non-Differential
JSG is the FDA product code for culture media, non-selective and non-differential. It is a Class I device, regulated under 21 CFR 866.2300 and reviewed by the Microbiology panel. FDA has cleared 209 510(k) submissions under JSG, from 40 different applicants. The average 510(k) review took 29 days (median 25). FDA has posted 29 recalls for JSG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Non-Selective And Non-Differential |
| Device class | Class I |
| Regulation | 21 CFR 866.2300 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JSG clearance
Top JSG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acumedia Manufacturers, Inc. | 42 | 1988-04-18 |
| Lakewood Biochemical Co., Inc. | 28 | 1988-07-01 |
| Otisville Biotech, Inc. | 17 | 1986-02-24 |
| Isle Media and Sterile Products, Inc. | 15 | 1983-07-28 |
| Hardy Media | 13 | 1988-03-30 |
35 more applicants have JSG clearances. See the full list in Caduvo.
Most recent JSG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K882495 | Lakewood Biochemical Co., Inc. | THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 | 1988-07-01 | 15 |
| K881522 | Acumedia Manufacturers, Inc. | DEXTROSE AGAR | 1988-04-18 | 10 |
| K881528 | Acumedia Manufacturers, Inc. | CASEIN PEPTONE, LOW VITAMIN | 1988-04-18 | 10 |
| K881541 | Acumedia Manufacturers, Inc. | GELATIN | 1988-04-18 | 10 |
| K881531 | Acumedia Manufacturers, Inc. | BLOOD AGAR BASE, IMPROVED | 1988-04-18 | 10 |
Recalls for JSG devices
29 product recalls in 13 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2019 | 14 |
| 2021 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JSG?
JSG is the FDA product code for culture media, non-selective and non-differential. It is a Class I device, regulated under 21 CFR 866.2300 and reviewed by the Microbiology panel.
What device class is JSG?
Class I, regulation 21 CFR 866.2300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSG?
Across 209 cleared submissions the average was 29 days from receipt to decision (median 25).
Which companies have the most JSG clearances?
Acumedia Manufacturers, Inc. (42); Lakewood Biochemical Co., Inc. (28); Otisville Biotech, Inc. (17); Isle Media and Sterile Products, Inc. (15); Hardy Media (13).
Have JSG devices been recalled?
Yes: 29 product recalls across 13 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code JSG
- Run a recall and safety report across every JSG manufacturer
- Watch product code JSG 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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