BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027

Visual, Pregnancy Hcg, Prescription Use

BIOCHECK, INC.

The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Hcg Enzyme Immunoassay Test Kit, Model Bc-1027.

Pre-market Notification Details

• Device ID: K991741
• 510k Number: K991741
• Device Name: BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
• Classification: Visual, Pregnancy Hcg, Prescription Use
• 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: JHI
• CFR Regulation Number: 862.1155 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-05-21
• Decision Date: 1999-07-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811727013255	K991741	000
B24225HCGHUE010	K991741	000
00840239017833	K991741	000
00850392007275	K991741	000