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FDA 510(k)

ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02

K-Number: K991762 · 1999-09-02

ApplicantA.P. Total Care, Inc.
Decision Date1999-09-02
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 is the device name listed in this FDA 510(k) record. The listed applicant is A.P. Total Care, Inc.. It received FDA 510(k) clearance on 1999-09-02 under 510(k) number K991762. 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 ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02?

ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 is a medical device that received FDA 510(k) clearance on 1999-09-02. The listed applicant is A.P. Total Care, Inc.. The 510(k) number is K991762.

When did ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 receive FDA 510(k) clearance?

ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 received FDA 510(k) clearance on 1999-09-02, under 510(k) number K991762.

Who is the listed applicant for ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02?

The FDA 510(k) record lists A.P. Total Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02?

The FDA product code for ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 is CJE.

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Other records listing A.P. Total Care, Inc. as applicant

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Related Devices (Code: CJE)

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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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