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FDA 510(k)

TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50

K-Number: K973108 · 1998-03-02

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1998-03-02
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1998-03-02 under 510(k) number K973108. 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 TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50?

TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 is a medical device that received FDA 510(k) clearance on 1998-03-02. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K973108.

When did TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 receive FDA 510(k) clearance?

TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 received FDA 510(k) clearance on 1998-03-02, under 510(k) number K973108.

Who is the listed applicant for TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50?

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

What is the FDA product code for TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50?

The FDA product code for TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 is CEK.

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Other records listing Diagnostic Chemicals , Ltd. 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.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.K955936TOTAL PROTEIN REAGENTDerma Media Lab., 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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