GLYCOHEMOGLOBIN IN WHOLE BLOOD— 510(k) K802721

Name: FDA 510(k) clearance K802721
Creator: U.S. Food and Drug Administration
Published: 1980-12-11

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K802721 for GLYCOHEMOGLOBIN IN WHOLE BLOOD, Substantially Equivalent on 1980-12-11. Applicant: Sigma Chemical Co.. Device class: 2.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1980-10-31
Decision date: 1980-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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