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FDA 510(k)

TOTAL PROTEIN REAGENT

K-Number: K955936 · 1996-03-12

ApplicantDerma Media Lab., Inc.
Decision Date1996-03-12
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTEIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Derma Media Lab., Inc.. It received FDA 510(k) clearance on 1996-03-12 under 510(k) number K955936. 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 REAGENT?

TOTAL PROTEIN REAGENT is a medical device that received FDA 510(k) clearance on 1996-03-12. The listed applicant is Derma Media Lab., Inc.. The 510(k) number is K955936.

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

TOTAL PROTEIN REAGENT received FDA 510(k) clearance on 1996-03-12, under 510(k) number K955936.

Who is the listed applicant for TOTAL PROTEIN REAGENT?

The FDA 510(k) record lists Derma Media Lab., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL PROTEIN REAGENT?

The FDA product code for TOTAL PROTEIN REAGENT is CEK.

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Other records listing Derma Media Lab., 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.

K970664GLUCOSE REAGENTK971309UREAK971072CHOLESTEROL REAGENTK971005TRIGLYCERIDESK970867URIC ACID REAGENTK964915MAGNESIUM

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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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