HEMOSITE TEST SYSTEM— 510(k) K994073

Substantially Equivalent

Gds Technology, LLC

FDA 510(k) clearance K994073 for HEMOSITE TEST SYSTEM, Substantially Equivalent on 2000-01-14. Applicant: Gds Technology, LLC.

Clearance details

Applicant: Gds Technology, LLC
Product code: Code KHG
Advisory panel: Hematology
Date received: 1999-12-02
Decision date: 2000-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

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