DeviceClearance

HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT— 510(k) K992148

Substantially Equivalent

Morax

FDA 510(k) clearance K992148 for HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT, Substantially Equivalent on 1999-12-29. Applicant: Morax.

Clearance details

Applicant
Morax
Product code
Code CGS
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chelsea, MI, US
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