FDA product code JSN: Culture Media, Propagating Transport
JSN is the FDA product code for culture media, propagating transport. It is a Class I device, regulated under 21 CFR 866.2390 and reviewed by the Microbiology panel. FDA has cleared 13 510(k) submissions under JSN, from 11 different applicants. The average 510(k) review took 44 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Propagating Transport |
| Device class | Class I |
| Regulation | 21 CFR 866.2390 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JSN clearance
Top JSN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Proteins Intl., Inc. | 2 | 1996-05-17 |
| Remel Co. | 2 | 1983-12-30 |
| Novamed , Ltd. | 1 | 2000-08-24 |
| Prepared Media Laboratory, Inc. | 1 | 1996-10-02 |
| Biomed Diagnostics, Inc. | 1 | 1990-01-29 |
6 more applicants have JSN clearances. See the full list in Caduvo.
Most recent JSN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000718 | Novamed , Ltd. | CHROMOSTREAK | 2000-08-24 | 174 |
| K962745 | Prepared Media Laboratory, Inc. | ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) | 1996-10-02 | 79 |
| K961756 | Proteins Intl., Inc. | CYTOQUANT VIRAL TRANSPORT MEDIUM | 1996-05-17 | 11 |
| K961755 | Proteins Intl., Inc. | CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM | 1996-05-17 | 11 |
| K896296 | Biomed Diagnostics, Inc. | INPOUCH-TV POUCH | 1990-01-29 | 90 |
Recalls for JSN devices
openFDA lists no recalls for product code JSN.
Frequently asked questions
What is FDA product code JSN?
JSN is the FDA product code for culture media, propagating transport. It is a Class I device, regulated under 21 CFR 866.2390 and reviewed by the Microbiology panel.
What device class is JSN?
Class I, regulation 21 CFR 866.2390. Typical premarket route: 510(k).
How long does a 510(k) take for product code JSN?
Across 13 cleared submissions the average was 44 days from receipt to decision (median 27).
Which companies have the most JSN clearances?
Proteins Intl., Inc. (2); Remel Co. (2); Novamed , Ltd. (1); Prepared Media Laboratory, Inc. (1); Biomed Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JSN
- Run a recall and safety report across every JSN manufacturer
- Watch product code JSN 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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