CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430— 510(k) K901380

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K901380 for CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430, Substantially Equivalent on 1990-05-25. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code GKP
Advisory panel: Hematology
Date received: 1990-03-22
Decision date: 1990-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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