BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

System, Test, Beta-2-microglobulin Immunological

BIOCHECK, INC.

The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck, Inc. B-2 Microglobin Enzyme Immunoasay Test Kit, Model Bc-1061.

Pre-market Notification Details

• Device ID: K001022
• 510k Number: K001022
• Device Name: BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
• Classification: System, Test, Beta-2-microglobulin Immunological
• 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: JZG
• CFR Regulation Number: 866.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-03-30
• Decision Date: 2000-09-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B24225BMGHUE010	K001022	000
00840239017895	K001022	000
00850392007619	K001022	000
04048474017892	K001022	000