Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

URIC ACID

K-Number: K771842 · 1977-10-25

ApplicantGamma Enterprises, Inc.
Decision Date1977-10-25
Product CodeCDH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URIC ACID is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Enterprises, Inc.. It received FDA 510(k) clearance on 1977-10-25 under 510(k) number K771842. 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?

URIC ACID is a medical device that received FDA 510(k) clearance on 1977-10-25. The listed applicant is Gamma Enterprises, Inc.. The 510(k) number is K771842.

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

URIC ACID received FDA 510(k) clearance on 1977-10-25, under 510(k) number K771842.

Who is the listed applicant for URIC ACID?

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

What is the FDA product code for URIC ACID?

The FDA product code for URIC ACID is CDH.

Other records listing Gamma Enterprises, 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.

K790578GAMMA SMAC REAGENTSK780507SERUM GLUTAMIC-PYRUVIC TRANSAMINASEK780506CARBON DIOXIDE REAGENTSK780505SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASEK780504CREATINE PHOSPHOKINASE (CPK)K771836LACTATE DEHYDROGENASE

View all 23 devices →

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.

↑