ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP— 510(k) K070146

Clearance details

Applicant

Horiba Abx

Product code

Code CDQ

Device class

Class 2

Regulation

21 CFR 862.1770

Advisory panel

Clinical Chemistry

Date received

2007-01-16

Decision date

2007-10-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Montpellier, FR

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