JMKClass I
Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
Clinical Chemistry · 21 CFR 862.1380
MDR events0All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances16All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
16 clearances for this product code
- Polymer Technology Systems, Inc.Dec 27, 1999
K983860 · MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
- Polymer Technology Systems, Inc.Feb 26, 1999
K981865 · MTM BIOSCANNER K TEST STRIPS
- Ihara Medics U.S., Inc.May 2, 1996
K953452 · KETOREX C SANWA
- Teco DiagnosticsMar 13, 1995
K941427 · SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
- Sigma Chemical Co.Jul 7, 1986
K862319 · HBDH (OPTIMIZED) REAGENT
- Reagents Applications, Inc.Oct 31, 1984
K843774 · RAICHEM X-HBDH REAGENT
- Gilford DiagnosticsOct 18, 1982
K822739 · AHBD
- Harleco DiagnosticsJul 14, 1982
K821877 · ULTRAZYME PLUS HBD