FDA product code JMK: Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
JMK is the FDA product code for acid, alpha-ketobutyric and nadh (u.v.), hydroxybutyric dehydrogenase. It is a Class I device, regulated under 21 CFR 862.1380 and reviewed by the Clinical Chemistry panel. FDA has cleared 16 510(k) submissions under JMK, from 11 different applicants. The average 510(k) review took 109 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase |
| Device class | Class I |
| Regulation | 21 CFR 862.1380 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JMK clearance
Top JMK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Harleco | 4 | 1978-02-13 |
| Polymer Technology Systems, Inc. | 2 | 1999-12-27 |
| Medical Analysis Systems, Inc. | 2 | 1978-11-03 |
| Ihara Medics U.S., Inc. | 1 | 1996-05-02 |
| Teco Diagnostics | 1 | 1995-03-13 |
6 more applicants have JMK clearances. See the full list in Caduvo.
Most recent JMK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K983860 | Polymer Technology Systems, Inc. | MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 | 1999-12-27 | 420 |
| K981865 | Polymer Technology Systems, Inc. | MTM BIOSCANNER K TEST STRIPS | 1999-02-26 | 274 |
| K953452 | Ihara Medics U.S., Inc. | KETOREX C SANWA | 1996-05-02 | 289 |
| K941427 | Teco Diagnostics | SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) | 1995-03-13 | 354 |
| K862319 | Sigma Chemical Co. | HBDH (OPTIMIZED) REAGENT | 1986-07-07 | 19 |
Recalls for JMK devices
openFDA lists no recalls for product code JMK.
Frequently asked questions
What is FDA product code JMK?
JMK is the FDA product code for acid, alpha-ketobutyric and nadh (u.v.), hydroxybutyric dehydrogenase. It is a Class I device, regulated under 21 CFR 862.1380 and reviewed by the Clinical Chemistry panel.
What device class is JMK?
Class I, regulation 21 CFR 862.1380. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JMK?
Across 16 cleared submissions the average was 109 days from receipt to decision (median 38).
Which companies have the most JMK clearances?
Harleco (4); Polymer Technology Systems, Inc. (2); Medical Analysis Systems, Inc. (2); Ihara Medics U.S., Inc. (1); Teco Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JMK
- Run a recall and safety report across every JMK manufacturer
- Watch product code JMK 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times