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FDA 510(k)

URIC ACID PROCEDURE, TEKPOINT DIRECT

K-Number: K770459 · 1977-04-29

ApplicantIcn Pharmaceuticals, Inc.
Decision Date1977-04-29
Product CodeCDH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID PROCEDURE, TEKPOINT DIRECT 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 1977-04-29 under 510(k) number K770459. The device is classified under product code CDH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIC ACID PROCEDURE, TEKPOINT DIRECT?

URIC ACID PROCEDURE, TEKPOINT DIRECT is a medical device that received FDA 510(k) clearance on 1977-04-29. The listed applicant is Icn Pharmaceuticals, Inc.. The 510(k) number is K770459.

When did URIC ACID PROCEDURE, TEKPOINT DIRECT receive FDA 510(k) clearance?

URIC ACID PROCEDURE, TEKPOINT DIRECT received FDA 510(k) clearance on 1977-04-29, under 510(k) number K770459.

Who is the listed applicant for URIC ACID PROCEDURE, TEKPOINT DIRECT?

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 URIC ACID PROCEDURE, TEKPOINT DIRECT?

The FDA product code for URIC ACID PROCEDURE, TEKPOINT DIRECT is CDH.

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Related Devices (Code: CDH)

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.

K850933URIC ACIDDilab, Inc.K841067URIC ACID REAGENT SETMedical Specialties, Inc.K821213URIC ACID REAGENT SETOmega Medical ElectronicsK813076PHOSPHOTUNGSTATE REDUCTION, URIC ACIDAmerican Monitor Corp.K810088URIC ACID (TPTZ) COLORINMETRICBio-Analytics Laboratories, Inc.K800672SMAC REPLACEMENT REAGENTS/DETERM-URIC-ACDiagnostic Solutions, 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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