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FDA 510(k)

COBAS REAGENT FOR TOTAL PROTEIN

K-Number: K823579 · 1983-01-07

ApplicantHoffmann-La Roche, Inc.
Decision Date1983-01-07
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS REAGENT FOR TOTAL PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823579. The device is classified under product code CEK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS REAGENT FOR TOTAL PROTEIN?

COBAS REAGENT FOR TOTAL PROTEIN is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K823579.

When did COBAS REAGENT FOR TOTAL PROTEIN receive FDA 510(k) clearance?

COBAS REAGENT FOR TOTAL PROTEIN received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823579.

Who is the listed applicant for COBAS REAGENT FOR TOTAL PROTEIN?

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

What is the FDA product code for COBAS REAGENT FOR TOTAL PROTEIN?

The FDA product code for COBAS REAGENT FOR TOTAL PROTEIN is CEK.

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Other records listing Hoffmann-La Roche, Inc. as applicant

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Related Devices (Code: CEK)

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.

K992846HICHEM TOTAL PROTEIN REAGENTElan Holdings, Inc.K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50Diagnostic Chemicals , Ltd.K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,Inc.

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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