HELENA BIOSTRIP A— 510(k) K830978

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K830978 for HELENA BIOSTRIP A, Substantially Equivalent on 1983-05-13. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JMA
Advisory panel: Clinical Chemistry
Date received: 1983-03-29
Decision date: 1983-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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