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FDA 510(k)

STAT KIT, MICROPROTEIN

K-Number: K781897 · 1979-01-10

ApplicantPierce Chemical Co.
Decision Date1979-01-10
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STAT KIT, MICROPROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Pierce Chemical Co.. It received FDA 510(k) clearance on 1979-01-10 under 510(k) number K781897. 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 STAT KIT, MICROPROTEIN?

STAT KIT, MICROPROTEIN is a medical device that received FDA 510(k) clearance on 1979-01-10. The listed applicant is Pierce Chemical Co.. The 510(k) number is K781897.

When did STAT KIT, MICROPROTEIN receive FDA 510(k) clearance?

STAT KIT, MICROPROTEIN received FDA 510(k) clearance on 1979-01-10, under 510(k) number K781897.

Who is the listed applicant for STAT KIT, MICROPROTEIN?

The FDA 510(k) record lists Pierce Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAT KIT, MICROPROTEIN?

The FDA product code for STAT KIT, MICROPROTEIN is CEK.

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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.

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Other records listing Pierce Chemical Co. 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.

K895661GLYCOTEST II GLYHB ASSAY KITK831837CLINOVATIVE II DIAGNOSTIC KITK821360GLYCO-GEL TEST KITK820279GLYCO-GEL TEST KITK780827URIC ACID RAPID STAT KITK780826BILIRUBIN RAPID STAT KIT

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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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