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Panels › Clinical Chemistry › Product code JMK · Class 1

Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase

Regulation 862.1380

0510(k)s in 12 months (16 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in JMK

Company510(k)sRecalls
Harleco40
Medical Analysis Systems, Inc.20
Polymer Technology Systems, Inc.20
Beckman Instruments, Inc.10
Gilford Diagnostics10
Harleco Diagnostics10
Ihara Medics U.S., Inc.10
Instrumentation Laboratory CO10
Reagents Applications, Inc.10
Sigma Chemical Co.10
Decided510(k)Device and applicantCode
Dec 27, 1999K983860MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
Polymer Technology Systems, Inc.
JMK
Feb 26, 1999K981865MTM BIOSCANNER K TEST STRIPS
Polymer Technology Systems, Inc.
JMK
May 2, 1996K953452KETOREX C SANWA
Ihara Medics U.S., Inc.
JMK
Mar 13, 1995K941427SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
Teco Diagnostics
JMK
Jul 7, 1986K862319HBDH (OPTIMIZED) REAGENT
Sigma Chemical Co.
JMK
Oct 31, 1984K843774RAICHEM X-HBDH REAGENT
Reagents Applications, Inc.
JMK
Oct 18, 1982K822739AHBD
Gilford Diagnostics
JMK
Jul 14, 1982K821877ULTRAZYME PLUS HBD
Harleco Diagnostics
JMK
Nov 3, 1978K781720HBDH ENZYME KINETIC REAGENT SET
Medical Analysis Systems, Inc.
JMK
Feb 13, 1978K780104ULTRAZYME PLUS HBD
Harleco
JMK
Feb 13, 1978K780073HBDH REAGENT SET
Medical Analysis Systems, Inc.
JMK
Feb 1, 1978K780042HYDORRYBUTYRATE DEHYDROGENASE
Beckman Instruments, Inc.
JMK
Nov 17, 1977K772033GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
Harleco
JMK
Sep 13, 1977K771474MULTISTAT III X-HBDH TEST
Instrumentation Laboratory CO
JMK
Jul 14, 1977K770871ULTRAZYME PLUS HBD
Harleco
JMK
Aug 26, 1976K760023ULTRAZYME HBD
Harleco
JMK

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