REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165— 510(k) K912386

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K912386 for REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165, Substantially Equivalent on 1991-07-17. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code CEF
Advisory panel: Clinical Chemistry
Date received: 1991-04-26
Decision date: 1991-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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