REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)— 510(k) K901463

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K901463 for REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO), Substantially Equivalent on 1990-06-12. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JQJ
Advisory panel: Clinical Chemistry
Date received: 1990-03-28
Decision date: 1990-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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