BIOSTREP A-DIRECT STREP A ANTIGEN TEST

Antigens, All Groups, Streptococcus Spp.

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biostrep A-direct Strep A Antigen Test.

Pre-market Notification Details

• Device ID: K983386
• 510k Number: K983386
• Device Name: BIOSTREP A-DIRECT STREP A ANTIGEN TEST
• Classification: Antigens, All Groups, Streptococcus Spp.
• Applicant: PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905
• Contact: Jemo Kang
• Correspondent: Jemo Kang; PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905
• Product Code: GTY
• CFR Regulation Number: 866.3740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-09-26
• Decision Date: 1998-11-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10763924513199	K983386	000