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FDA 510(k)

KINETIC ALKALINE PHOSPHATASE DETERMINATION

K-Number: K905650 · 1991-02-13

ApplicantBiochemical Trade, Inc.
Decision Date1991-02-13
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KINETIC ALKALINE PHOSPHATASE DETERMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Biochemical Trade, Inc.. It received FDA 510(k) clearance on 1991-02-13 under 510(k) number K905650. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KINETIC ALKALINE PHOSPHATASE DETERMINATION?

KINETIC ALKALINE PHOSPHATASE DETERMINATION is a medical device that received FDA 510(k) clearance on 1991-02-13. The listed applicant is Biochemical Trade, Inc.. The 510(k) number is K905650.

When did KINETIC ALKALINE PHOSPHATASE DETERMINATION receive FDA 510(k) clearance?

KINETIC ALKALINE PHOSPHATASE DETERMINATION received FDA 510(k) clearance on 1991-02-13, under 510(k) number K905650.

Who is the listed applicant for KINETIC ALKALINE PHOSPHATASE DETERMINATION?

The FDA 510(k) record lists Biochemical Trade, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KINETIC ALKALINE PHOSPHATASE DETERMINATION?

The FDA product code for KINETIC ALKALINE PHOSPHATASE DETERMINATION is CJE.

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Other records listing Biochemical Trade, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942958CREATINE KINASE MB DETERMINATION (UV)K910635TOTAL BILIRUBIN REAGENT SETK910296PHOSPHORUS (INORGANIC) TEST SYSTEMK905776ALBUMIN REAGENT SETK905790TOTAL PROTEIN REAGENT SETK905619CREATININE (RATE) REAGENT SET

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Related Devices (Code: CJE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251074Tru Liver Health Test PanelTruvian HealthK240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK223317Alkaline Phosphatase2Abbott Ireland Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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