TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS— 510(k) K040459

Clearance details

Applicant

Biosite Incorporated

Product code

Code JJY

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

2004-02-23

Decision date

2004-07-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Diego, CA, US

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