SANDARE GLYCOHEMOGLOBIN PROCEDURE— 510(k) K802832

Name: FDA 510(k) clearance K802832
Creator: U.S. Food and Drug Administration
Published: 1981-01-16

Substantially Equivalent

Sandare Chemical Co., Inc.

FDA 510(k) clearance K802832 for SANDARE GLYCOHEMOGLOBIN PROCEDURE, Substantially Equivalent on 1981-01-16. 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: 1980-11-12
Decision date: 1981-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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