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FDA 510(k)

BIURET REAGENT & TOTAL PROTEIN BLANK SOL

K-Number: K802161 · 1980-10-10

ApplicantPanmed, Inc.
Decision Date1980-10-10
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIURET REAGENT & TOTAL PROTEIN BLANK SOL is the device name listed in this FDA 510(k) record. The listed applicant is Panmed, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802161. 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 BIURET REAGENT & TOTAL PROTEIN BLANK SOL?

BIURET REAGENT & TOTAL PROTEIN BLANK SOL is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Panmed, Inc.. The 510(k) number is K802161.

When did BIURET REAGENT & TOTAL PROTEIN BLANK SOL receive FDA 510(k) clearance?

BIURET REAGENT & TOTAL PROTEIN BLANK SOL received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802161.

Who is the listed applicant for BIURET REAGENT & TOTAL PROTEIN BLANK SOL?

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

What is the FDA product code for BIURET REAGENT & TOTAL PROTEIN BLANK SOL?

The FDA product code for BIURET REAGENT & TOTAL PROTEIN BLANK SOL is CEK.

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Other records listing Panmed, 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.

K852767ERYTHOCYTE CREATINEK820642SICKLE-CHECKK8021648-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.K802157BCG REAGENT SERUM ALBUMIN W/TECHNICONK802163CHLORIDE COLOR & CHLORIDE SAMPLE DILUENTK802155REAGENTS SERUM SODIUM USING THE TECH.

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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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