FETAL-TEK CONTROL MATURE— 510(k) K820319

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K820319 for FETAL-TEK CONTROL MATURE, Substantially Equivalent on 1982-03-25. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJS
Advisory panel: Clinical Chemistry
Date received: 1982-02-05
Decision date: 1982-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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