HEMESPEC— 510(k) K782035

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K782035 for HEMESPEC, Substantially Equivalent on 1979-01-17. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJQ
Advisory panel: Clinical Chemistry
Date received: 1978-12-06
Decision date: 1979-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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