ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H

Single (specified) Analyte Controls (assayed And Unassayed)

MEDICAL ANALYSIS SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M And H.

Pre-market Notification Details

• Device ID: K041194
• 510k Number: K041194
• Device Name: ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
• Classification: Single (specified) Analyte Controls (assayed And Unassayed)
• Applicant: MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012
• Contact: Mary Thorsness
• Correspondent: Mary Thorsness; MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012
• Product Code: JJX
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-05-06
• Decision Date: 2004-08-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00380740003197	K041194	000