JMK · Class I · 21 CFR 862.1380

FDA Product Code JMK: Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase

Leading manufacturers include Harleco, Medical Analysis Systems, Inc. and Polymer Technology Systems, Inc..

16
Total
16
Cleared
109d
Avg days
1976
Since

FDA 510(k) Cleared Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase Devices (Product Code JMK)

16 devices
1–16 of 16
Cleared Dec 27, 1999
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
K983860
Polymer Technology Systems, Inc.
Chemistry · 420d
Cleared Feb 26, 1999
MTM BIOSCANNER K TEST STRIPS
K981865
Polymer Technology Systems, Inc.
Chemistry · 274d
Cleared Mar 13, 1995
SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
K941427
Teco Diagnostics
Chemistry · 354d
Cleared Jul 07, 1986
HBDH (OPTIMIZED) REAGENT
K862319
Sigma Chemical Co.
Chemistry · 19d
Cleared Oct 31, 1984
RAICHEM X-HBDH REAGENT
K843774
Reagents Applications, Inc.
Chemistry · 36d
Cleared Oct 18, 1982
AHBD
K822739
Gilford Diagnostics
Chemistry · 39d
Cleared Nov 03, 1978
HBDH ENZYME KINETIC REAGENT SET
K781720
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Feb 13, 1978
HBDH REAGENT SET
K780073
Medical Analysis Systems, Inc.
Chemistry · 28d
Cleared Feb 13, 1978
ULTRAZYME PLUS HBD
K780104
Harleco
Chemistry · 24d
Cleared Feb 01, 1978
HYDORRYBUTYRATE DEHYDROGENASE
K780042
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
K772033
Harleco
Chemistry · 21d
Cleared Sep 13, 1977
MULTISTAT III X-HBDH TEST
K771474
Instrumentation Laboratory CO
Chemistry · 40d
Cleared Jul 14, 1977
ULTRAZYME PLUS HBD
K770871
Harleco
Chemistry · 62d
Cleared Aug 26, 1976
ULTRAZYME HBD
K760023
Harleco
Chemistry · 73d

About Product Code JMK - Regulatory Context