I-STAT KAOLIN ACT TEST— 510(k) K023582

Clearance details

Applicant

I-Stat Corporation

Product code

Code JBP

Device class

Class 2

Regulation

21 CFR 864.7140

Advisory panel

Hematology

Date received

2002-10-24

Decision date

2003-09-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

East Windsor, NJ, US

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