Product Code: JMK FDA class 1 21 CFR 862.1380

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

Clinical Chemistry

This device is a clinical chemistry reagent system using alpha-ketobutyric acid and NADH in an ultraviolet spectrophotometric assay to measure hydroxybutyric dehydrogenase activity in patient serum, an enzymatic indicator associated with myocardial infarction and hepatic disease when elevated. It is classified as FDA Class 1, the lowest risk category, requiring only general controls with no premarket notification. The product code is JMK, regulated under 21 CFR 862.1380, within the Clinical Chemistry medical specialty.

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Basic Information

Product Code: JMK
Device Class: FDA class 1
Regulation Number: 862.1380
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 16 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K983860	MTM BIOSCANNER K TEST STRIPS, CAT # BSA610	Dec 27, 1999	Substantially Equivalent	Polymer Technology Systems, Inc.
K981865	MTM BIOSCANNER K TEST STRIPS	Feb 26, 1999	Substantially Equivalent	Polymer Technology Systems, Inc.
K953452	KETOREX C SANWA	May 02, 1996	Substantially Equivalent	Ihara Medics U.S., Inc.
K941427	SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)	Mar 13, 1995	Substantially Equivalent	Teco Diagnostics
K862319	HBDH (OPTIMIZED) REAGENT	Jul 07, 1986	Substantially Equivalent	Sigma Chemical Co.
K843774	RAICHEM X-HBDH REAGENT	Oct 31, 1984	Substantially Equivalent	Reagents Applications, Inc.
K822739	AHBD	Oct 18, 1982	Substantially Equivalent	Gilford Diagnostics
K821877	ULTRAZYME PLUS HBD	Jul 14, 1982	Substantially Equivalent	Harleco Diagnostics
K781720	HBDH ENZYME KINETIC REAGENT SET	Nov 03, 1978	Substantially Equivalent	Medical Analysis Systems, Inc.
K780104	ULTRAZYME PLUS HBD	Feb 13, 1978	Substantially Equivalent	Harleco
K780073	HBDH REAGENT SET	Feb 13, 1978	Substantially Equivalent	Medical Analysis Systems, Inc.
K780042	HYDORRYBUTYRATE DEHYDROGENASE	Feb 01, 1978	Substantially Equivalent	Beckman Instruments, Inc.
K772033	GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*	Nov 17, 1977	Substantially Equivalent	Harleco
K771474	MULTISTAT III X-HBDH TEST	Sep 13, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K770871	ULTRAZYME PLUS HBD	Jul 14, 1977	Substantially Equivalent	Harleco
K760023	ULTRAZYME HBD	Aug 26, 1976	Substantially Equivalent	Harleco