REP(TM) SPE PLUS-30 PROCEDURES— 510(k) K896572

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K896572 for REP(TM) SPE PLUS-30 PROCEDURES, Substantially Equivalent on 1990-01-11. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code CFP
Advisory panel: Clinical Chemistry
Date received: 1989-11-20
Decision date: 1990-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.