HELENA FETAL-TEK 200 METHOD— 510(k) K811588

Name: FDA 510(k) clearance K811588
Creator: U.S. Food and Drug Administration
Published: 1981-06-25

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K811588 for HELENA FETAL-TEK 200 METHOD, Substantially Equivalent on 1981-06-25. Applicant: Helena Laboratories. Device class: 2.

Clearance details

Applicant: Helena Laboratories
Product code: Code JHG
Device class: Class 2
Regulation: 21 CFR 862.1455
Advisory panel: Clinical Chemistry
Date received: 1981-06-08
Decision date: 1981-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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