LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS— 510(k) K030150

Name: FDA 510(k) clearance K030150
Creator: U.S. Food and Drug Administration
Published: 2003-01-28

Substantially Equivalent

Cliniqa Corporation

FDA 510(k) clearance K030150 for LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS, Substantially Equivalent on 2003-01-28. Applicant: Cliniqa Corporation. Device class: 1.

Clearance details

Applicant: Cliniqa Corporation
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2003-01-15
Decision date: 2003-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fallbrook, CA, US

Download summary PDF View on FDA.gov ↗

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