SANDARE URIC ACID PROCEDURE— 510(k) K812313

Name: FDA 510(k) clearance K812313
Creator: U.S. Food and Drug Administration
Published: 1981-09-01

Substantially Equivalent

Sandare Chemical Co., Inc.

FDA 510(k) clearance K812313 for SANDARE URIC ACID PROCEDURE, Substantially Equivalent on 1981-09-01. Applicant: Sandare Chemical Co., Inc.. Device class: 1.

Clearance details

Applicant: Sandare Chemical Co., Inc.
Product code: Code LFQ
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1981-08-17
Decision date: 1981-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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