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FDA 510(k)

ALP(ALKALINE)(PHOSPHATASE) REAGENT

K-Number: K851998 · 1985-05-30

ApplicantAlpkem Corp.
Decision Date1985-05-30
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 Alpkem Corp.. It received FDA 510(k) clearance on 1985-05-30 under 510(k) number K851998. 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 1985-05-30. The listed applicant is Alpkem Corp.. The 510(k) number is K851998.

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

ALP(ALKALINE)(PHOSPHATASE) REAGENT received FDA 510(k) clearance on 1985-05-30, under 510(k) number K851998.

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

The FDA 510(k) record lists Alpkem Corp. 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 Alpkem Corp. 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.

K894011TOTAL GALACTOSEK891070PHENYLALANINE (NINHYDRIN REACTION)K890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTER

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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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