LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS— 510(k) K032074

Name: FDA 510(k) clearance K032074
Creator: U.S. Food and Drug Administration
Published: 2003-10-21

Substantially Equivalent

Cliniqa Corporation

FDA 510(k) clearance K032074 for LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS, Substantially Equivalent on 2003-10-21. 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: 2003-07-07
Decision date: 2003-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fallbrook, CA, US

Download summary PDF View on FDA.gov ↗

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