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

Clearance details

Applicant

Morax

Product code

Code CGS

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

1999-06-24

Decision date

1999-12-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chelsea, MI, US

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