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FDA 510(k)

ALP (ALKALINE PHOSPHATASE) REAGENT

K-Number: K860715 · 1986-04-24

ApplicantTrace Scientific , Ltd.
Decision Date1986-04-24
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALP (ALKALINE PHOSPHATASE) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1986-04-24 under 510(k) number K860715. 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 ALP (ALKALINE PHOSPHATASE) REAGENT?

ALP (ALKALINE PHOSPHATASE) REAGENT is a medical device that received FDA 510(k) clearance on 1986-04-24. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K860715.

When did ALP (ALKALINE PHOSPHATASE) REAGENT receive FDA 510(k) clearance?

ALP (ALKALINE PHOSPHATASE) REAGENT received FDA 510(k) clearance on 1986-04-24, under 510(k) number K860715.

Who is the listed applicant for ALP (ALKALINE PHOSPHATASE) REAGENT?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALP (ALKALINE PHOSPHATASE) REAGENT?

The FDA product code for ALP (ALKALINE PHOSPHATASE) REAGENT is CJE.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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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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