FDA Product Code JMK: Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
Leading manufacturers include Harleco, Polymer Technology Systems, Inc. and Medical Analysis 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
Cleared
Dec 27, 1999
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
Polymer Technology Systems, Inc.
Chemistry
420d
Cleared
Feb 26, 1999
MTM BIOSCANNER K TEST STRIPS
Polymer Technology Systems, Inc.
Chemistry
274d
Cleared
May 02, 1996
KETOREX C SANWA
Ihara Medics U.S., Inc.
Chemistry
289d
Cleared
Mar 13, 1995
SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
Teco Diagnostics
Chemistry
354d
Cleared
Jul 07, 1986
HBDH (OPTIMIZED) REAGENT
Sigma Chemical Co.
Chemistry
19d
Cleared
Oct 31, 1984
RAICHEM X-HBDH REAGENT
Reagents Applications, Inc.
Chemistry
36d
Cleared
Oct 18, 1982
AHBD
Gilford Diagnostics
Chemistry
39d
Cleared
Jul 14, 1982
ULTRAZYME PLUS HBD
Harleco Diagnostics
Chemistry
19d
Cleared
Nov 03, 1978
HBDH ENZYME KINETIC REAGENT SET
Medical Analysis Systems, Inc.
Chemistry
23d
Cleared
Feb 13, 1978
HBDH REAGENT SET
Medical Analysis Systems, Inc.
Chemistry
28d
Cleared
Feb 13, 1978
ULTRAZYME PLUS HBD
Harleco
Chemistry
24d
Cleared
Feb 01, 1978
HYDORRYBUTYRATE DEHYDROGENASE
Beckman Instruments, Inc.
Chemistry
23d
Cleared
Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
Harleco
Chemistry
21d
Cleared
Sep 13, 1977
MULTISTAT III X-HBDH TEST
Instrumentation Laboratory CO
Chemistry
40d
Cleared
Jul 14, 1977
ULTRAZYME PLUS HBD
Harleco
Chemistry
62d
Cleared
Aug 26, 1976
ULTRAZYME HBD
Harleco
Chemistry
73d