MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL

Multi-analyte Controls, All Kinds (assayed)

MEDICAL ANALYSIS SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Modification To Mas Cardiolmmune Tl; Dade Cardiac Tl.

Pre-market Notification Details

• Device ID: K013995
• 510k Number: K013995
• Device Name: MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012
• Contact: Penny M Layman
• Correspondent: Penny M Layman; MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012
• Product Code: JJY
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-12-04
• Decision Date: 2001-12-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00380740003289	K013995	000
00380740003234	K013995	000