LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS

Multi-analyte Controls, All Kinds (assayed)

CLINIQA CORPORATION

The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Linical Protein 3 Calibration Verifiers Levels A-e For The Olympus Au Series Chemistry Immuno Analyzers.

Pre-market Notification Details

• Device ID: K030566
• 510k Number: K030566
• Device Name: LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: CLINIQA CORPORATION 1432 SOUTH MISSION RD. Fallbrook, CA 92028
• Contact: Carol Ruggiero
• Correspondent: Carol Ruggiero; CLINIQA CORPORATION 1432 SOUTH MISSION RD. Fallbrook, CA 92028
• Product Code: JJY
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-02-24
• Decision Date: 2003-03-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817238010684	K030566	000