KEMTROL SERUM CONTROL ABNORMAL— 510(k) K802109

Substantially Equivalent

Helena Laboratories

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

Clearance details

Applicant: Helena Laboratories
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1980-09-03
Decision date: 1980-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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