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FDA 510(k)

URIC ACID TEST KIT

K-Number: K770564 · 1977-06-03

ApplicantMallinckrodt Critical Care
Decision Date1977-06-03
Product CodeCDH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1977-06-03 under 510(k) number K770564. 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 TEST KIT?

URIC ACID TEST KIT is a medical device that received FDA 510(k) clearance on 1977-06-03. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K770564.

When did URIC ACID TEST KIT receive FDA 510(k) clearance?

URIC ACID TEST KIT received FDA 510(k) clearance on 1977-06-03, under 510(k) number K770564.

Who is the listed applicant for URIC ACID TEST KIT?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URIC ACID TEST KIT?

The FDA product code for URIC ACID TEST KIT is CDH.

Other records listing Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

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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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