HYDRAGEL 15 HB A1C KIT— 510(k) K963844

Substantially Equivalent

Morax

FDA 510(k) clearance K963844 for HYDRAGEL 15 HB A1C KIT, Substantially Equivalent on 1997-04-22. Applicant: Morax.

Clearance details

Applicant: Morax
Product code: Code LCP
Advisory panel: Hematology
Date received: 1996-09-25
Decision date: 1997-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelsea, MI, US

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