HEMOCUE HEMOTROL— 510(k) K964052

Substantially Equivalent

Direct Solutions

FDA 510(k) clearance K964052 for HEMOCUE HEMOTROL, Substantially Equivalent on 1996-11-06. Applicant: Direct Solutions.

Clearance details

Applicant: Direct Solutions
Product code: Code GGM
Advisory panel: Hematology
Date received: 1996-09-30
Decision date: 1996-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westford, MA, US

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