HEMOSITE TEST SYSTEM— 510(k) K973649

Substantially Equivalent

Gds Technology, LLC

FDA 510(k) clearance K973649 for HEMOSITE TEST SYSTEM, Substantially Equivalent on 1998-08-31. Applicant: Gds Technology, LLC.

Clearance details

Applicant: Gds Technology, LLC
Product code: Code KHG
Advisory panel: Hematology
Date received: 1997-09-25
Decision date: 1998-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.