CARDIO REP LD CONTROL - CAT NO. 3325— 510(k) K950801

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K950801 for CARDIO REP LD CONTROL - CAT NO. 3325, Substantially Equivalent on 1995-03-30. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJT
Advisory panel: Clinical Chemistry
Date received: 1995-02-21
Decision date: 1995-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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