GLYCOSYLATED HEMOGLOBIN-SMC COLUMN— 510(k) K802233

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K802233 for GLYCOSYLATED HEMOGLOBIN-SMC COLUMN, Substantially Equivalent on 1980-10-10. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code LCP
Advisory panel: Hematology
Date received: 1980-09-15
Decision date: 1980-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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