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FDA 510(k)

SERUM TOTAL PROTEIN REAGENT SET

K-Number: K841069 · 1984-05-01

ApplicantMedical Specialties, Inc.
Decision Date1984-05-01
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM TOTAL PROTEIN REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties, Inc.. It received FDA 510(k) clearance on 1984-05-01 under 510(k) number K841069. 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 SERUM TOTAL PROTEIN REAGENT SET?

SERUM TOTAL PROTEIN REAGENT SET is a medical device that received FDA 510(k) clearance on 1984-05-01. The listed applicant is Medical Specialties, Inc.. The 510(k) number is K841069.

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

SERUM TOTAL PROTEIN REAGENT SET received FDA 510(k) clearance on 1984-05-01, under 510(k) number K841069.

Who is the listed applicant for SERUM TOTAL PROTEIN REAGENT SET?

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

What is the FDA product code for SERUM TOTAL PROTEIN REAGENT SET?

The FDA product code for SERUM TOTAL PROTEIN REAGENT SET is CEK.

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Other records listing Medical Specialties, 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.

K946201STAND, INFUSIONK931947CHECKPOINTK926095REFRACTROL-SPK924926MSI-HCTK896566MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVEK883851MSI-CAL 8

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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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