Atlas FDA

JMK

16 FDA 510(k) clearances · Product code

39 daysmedian time to decision
354 days90th percentile
16clearances measured

FDA profile

Official device name
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Device class
Class I (low risk)
Regulation
21 CFR 862.1380
Medical specialty
Clinical Chemistry
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RecordFirmDate
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 (K983860)Polymer Technology Systems, Inc.1999-12-27
MTM BIOSCANNER K TEST STRIPS (K981865)Polymer Technology Systems, Inc.1999-02-26
KETOREX C SANWA (K953452)Ihara Medics U.S., Inc.1996-05-02
SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) (K941427)Teco Diagnostics1995-03-13
HBDH (OPTIMIZED) REAGENT (K862319)Sigma Chemical Co.1986-07-07
RAICHEM X-HBDH REAGENT (K843774)Reagents Applications, Inc.1984-10-31
AHBD (K822739)Gilford Diagnostics1982-10-18
ULTRAZYME PLUS HBD (K821877)Harleco Diagnostics1982-07-14
HBDH ENZYME KINETIC REAGENT SET (K781720)Medical Analysis Systems, Inc.1978-11-03
ULTRAZYME PLUS HBD (K780104)Harleco1978-02-13
HBDH REAGENT SET (K780073)Medical Analysis Systems, Inc.1978-02-13
HYDORRYBUTYRATE DEHYDROGENASE (K780042)Beckman Instruments, Inc.1978-02-01
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* (K772033)Harleco1977-11-17
MULTISTAT III X-HBDH TEST (K771474)Instrumentation Laboratory CO1977-09-13
ULTRAZYME PLUS HBD (K770871)Harleco1977-07-14
ULTRAZYME HBD (K760023)Harleco1976-08-26

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Every clearance here is in the API, with alerts when new ones post.