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. Device class: 2.

Clearance details

Applicant: Gds Technology, LLC
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
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 ↗

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K882038 — GDS ENZYMATIC SALICYLATE REAGENT1988-06-24

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