EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST— 510(k) K872852

Name: FDA 510(k) clearance K872852
Creator: U.S. Food and Drug Administration
Published: 1987-09-29

Substantially Equivalent

Sandare Chemical Co., Inc.

FDA 510(k) clearance K872852 for EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST, Substantially Equivalent on 1987-09-29. Applicant: Sandare Chemical Co., Inc.. Device class: 2.

Clearance details

Applicant: Sandare Chemical Co., Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1987-07-20
Decision date: 1987-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Desoto, TX, US

Download summary PDF View on FDA.gov ↗

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