REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172— 510(k) K913058

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K913058 for REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172, Substantially Equivalent on 1991-10-30. Applicant: Helena Laboratories.

Clearance details

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

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