FDA product code JSD: Culture Media, Selective Broth
JSD is the FDA product code for culture media, selective broth. It is a Class I device, regulated under 21 CFR 866.2360 and reviewed by the Microbiology panel. FDA has cleared 26 510(k) submissions under JSD, from 18 different applicants. The average 510(k) review took 33 days (median 30). FDA has posted 2 recalls for JSD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Selective Broth |
| Device class | Class I |
| Regulation | 21 CFR 866.2360 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JSD clearance
Top JSD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Isle Media and Sterile Products, Inc. | 4 | 1979-09-17 |
| Lakewood Biochemical Co., Inc. | 3 | 1987-10-02 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1987-05-13 |
| Micro Media Laboratories | 2 | 1983-12-27 |
| Granite Diagnostics, Inc. | 2 | 1982-08-03 |
13 more applicants have JSD clearances. See the full list in Caduvo.
Most recent JSD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883075 | Baxter Healthcare Corp | FASTIDIOUS INOCULUM BROTH | 1988-08-15 | 33 |
| K880107 | Hardy Media | CAMPY BROTH | 1988-03-30 | 84 |
| K873324 | Lakewood Biochemical Co., Inc. | SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 | 1987-10-02 | 45 |
| K873218 | Lakewood Biochemical Co., Inc. | BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 | 1987-09-23 | 40 |
| K871447 | Remel Co. | TODD HEWITT W/CNA (LIM BROTH) | 1987-05-13 | 30 |
Recalls for JSD devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-08-14.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code JSD?
JSD is the FDA product code for culture media, selective broth. It is a Class I device, regulated under 21 CFR 866.2360 and reviewed by the Microbiology panel.
What device class is JSD?
Class I, regulation 21 CFR 866.2360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSD?
Across 26 cleared submissions the average was 33 days from receipt to decision (median 30).
Which companies have the most JSD clearances?
Isle Media and Sterile Products, Inc. (4); Lakewood Biochemical Co., Inc. (3); Bd Becton Dickinson Vacutainer Systems Preanalytic (2); Micro Media Laboratories (2); Granite Diagnostics, Inc. (2).
Have JSD devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-08-14.
Next steps
- Run an FDA pathway report with predicate devices for product code JSD
- Run a recall and safety report across every JSD manufacturer
- Watch product code JSD 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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