URIC ACID, BOUND ENZYME— 510(k) K790092

Name: FDA 510(k) clearance K790092
Creator: U.S. Food and Drug Administration
Published: 1979-03-12

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K790092 for URIC ACID, BOUND ENZYME, Substantially Equivalent on 1979-03-12. Applicant: Technicon Instruments Corp.. Device class: 1.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code KNK
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1979-01-16
Decision date: 1979-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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