REP ALP-15, 8, & 4 KITS— 510(k) K912603

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K912603 for REP ALP-15, 8, & 4 KITS, Substantially Equivalent on 1991-07-30. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code CIN
Advisory panel: Clinical Chemistry
Date received: 1991-06-10
Decision date: 1991-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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