REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175— 510(k) K922024

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K922024 for REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175, Substantially Equivalent on 1992-07-23. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code CEF
Advisory panel: Clinical Chemistry
Date received: 1992-05-01
Decision date: 1992-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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