FETAL MATURITY TEST PROCEDURE— 510(k) K790798

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K790798 for FETAL MATURITY TEST PROCEDURE, Substantially Equivalent on 1979-06-05. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JHG
Advisory panel: Clinical Chemistry
Date received: 1979-04-17
Decision date: 1979-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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