BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT

Immunoassay Method, Troponin Subunit

BIOCHECK, INC.

The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Human Cardiac Troponin-i Immunoassay Test Kit.

Pre-market Notification Details

• Device ID: K013062
• 510k Number: K013062
• Device Name: BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
• Classification: Immunoassay Method, Troponin Subunit
• Applicant: BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325
• Contact: Robin J Hellen
• Correspondent: Robin J Hellen; BIOCHECK, INC. 9418 LASAINE AVE. Northridge, CA 91325
• Product Code: MMI
• CFR Regulation Number: 862.1215 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-09-12
• Decision Date: 2002-01-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811727013347	K013062	000
00083059070316	K013062	000
08305900070316	K013062	000