HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH— 510(k) K800857

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K800857 for HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH, Substantially Equivalent on 1980-09-26. Applicant: Helena Laboratories.

Clearance details

Applicant
Helena Laboratories
Product code
Code LCP
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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