REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT— 510(k) K935162

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K935162 for REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT, Substantially Equivalent on 1994-11-10. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JHO
Advisory panel: Clinical Chemistry
Date received: 1993-10-29
Decision date: 1994-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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