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FDA 510(k)

COBAS REAGENT FOR ALKALINE PHOSPHATASE

K-Number: K801242 · 1980-06-20

ApplicantRoche Analytical Instruments, Inc.
Decision Date1980-06-20
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS REAGENT FOR ALKALINE PHOSPHATASE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Analytical Instruments, Inc.. It received FDA 510(k) clearance on 1980-06-20 under 510(k) number K801242. 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 COBAS REAGENT FOR ALKALINE PHOSPHATASE?

COBAS REAGENT FOR ALKALINE PHOSPHATASE is a medical device that received FDA 510(k) clearance on 1980-06-20. The listed applicant is Roche Analytical Instruments, Inc.. The 510(k) number is K801242.

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

COBAS REAGENT FOR ALKALINE PHOSPHATASE received FDA 510(k) clearance on 1980-06-20, under 510(k) number K801242.

Who is the listed applicant for COBAS REAGENT FOR ALKALINE PHOSPHATASE?

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

What is the FDA product code for COBAS REAGENT FOR ALKALINE PHOSPHATASE?

The FDA product code for COBAS REAGENT FOR ALKALINE PHOSPHATASE is CJE.

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Other records listing Roche Analytical Instruments, 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.

K801299COBAS CK-NAC REAGENTK801295COBAS REAGENT FOR A-AMYLASEK801298COBAS REAGENT FOR TRIGLYCERIDES & COBASK801296COBAS REAGENT FOR CHOLESTEROLK801297COBAS REAGENT FOR GLUCOSE RAPIDK801243COBAS REAGENTS FOR URIC ACID

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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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