TOTAL PROTEIN PROCEDURE— 510(k) K832169

Name: FDA 510(k) clearance K832169
Creator: U.S. Food and Drug Administration
Published: 1983-08-16

Substantially Equivalent

Sandare Chemical Co., Inc.

FDA 510(k) clearance K832169 for TOTAL PROTEIN PROCEDURE, Substantially Equivalent on 1983-08-16. Applicant: Sandare Chemical Co., Inc.. Device class: 2.

Clearance details

Applicant: Sandare Chemical Co., Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1983-07-06
Decision date: 1983-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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