REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175— 510(k) K900251

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K900251 for REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175, Substantially Equivalent on 1990-02-26. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code CEF
Advisory panel: Clinical Chemistry
Date received: 1990-01-17
Decision date: 1990-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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