CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL

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 Cliniqa Liquid Qc Tumor Marker Control Level 1, Level 2, Level 3, And Tri Level.

Pre-market Notification Details

• Device ID: K030705
• 510k Number: K030705
• Device Name: CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL
• 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: 2003-03-06
• Decision Date: 2003-03-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817238010158	K030705	000
00817238010134	K030705	000
00817238010127	K030705	000
00817238010103	K030705	000