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FDA 510(k)

ENZAC URIC ACID 100-TEST KIT

K-Number: K772082 · 1977-11-28

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1977-11-28
Product CodeCDH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZAC URIC ACID 100-TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1977-11-28 under 510(k) number K772082. 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 ENZAC URIC ACID 100-TEST KIT?

ENZAC URIC ACID 100-TEST KIT is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K772082.

When did ENZAC URIC ACID 100-TEST KIT receive FDA 510(k) clearance?

ENZAC URIC ACID 100-TEST KIT received FDA 510(k) clearance on 1977-11-28, under 510(k) number K772082.

Who is the listed applicant for ENZAC URIC ACID 100-TEST KIT?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENZAC URIC ACID 100-TEST KIT?

The FDA product code for ENZAC URIC ACID 100-TEST KIT 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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