KEMTROL SERUM CONTROL ABNORMAL— 510(k) K802109

Name: FDA 510(k) clearance K802109
Creator: U.S. Food and Drug Administration
Published: 1980-10-10

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K802109 for KEMTROL SERUM CONTROL ABNORMAL, Substantially Equivalent on 1980-10-10. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1980-09-03
Decision date: 1980-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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