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FDA 510(k)

PROTEIN PROCEDURE, TEKPOINT TOTAL

K-Number: K770452 · 1977-05-03

ApplicantIcn Pharmaceuticals, Inc.
Decision Date1977-05-03
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROTEIN PROCEDURE, TEKPOINT TOTAL is the device name listed in this FDA 510(k) record. The listed applicant is Icn Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1977-05-03 under 510(k) number K770452. 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 PROTEIN PROCEDURE, TEKPOINT TOTAL?

PROTEIN PROCEDURE, TEKPOINT TOTAL is a medical device that received FDA 510(k) clearance on 1977-05-03. The listed applicant is Icn Pharmaceuticals, Inc.. The 510(k) number is K770452.

When did PROTEIN PROCEDURE, TEKPOINT TOTAL receive FDA 510(k) clearance?

PROTEIN PROCEDURE, TEKPOINT TOTAL received FDA 510(k) clearance on 1977-05-03, under 510(k) number K770452.

Who is the listed applicant for PROTEIN PROCEDURE, TEKPOINT TOTAL?

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

What is the FDA product code for PROTEIN PROCEDURE, TEKPOINT TOTAL?

The FDA product code for PROTEIN PROCEDURE, TEKPOINT TOTAL is CEK.

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Related Devices (Code: CEK)

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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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