BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB

System, Test, Infectious Mononucleosis

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biosign Mono-plus Wb,biosign Mono Wb,mono-plus Wb,accusign Mono Wb.

Pre-market Notification Details

• Device ID: K961024
• 510k Number: K961024
• Device Name: BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
• Classification: System, Test, Infectious Mononucleosis
• Applicant: PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905
• Contact: Jeno Kang, Ph.d.
• Correspondent: Jeno Kang, Ph.d.; PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905
• Product Code: KTN
• CFR Regulation Number: 866.5640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-03-14
• Decision Date: 1997-02-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816917021546	K961024	000
15099590625900	K961024	000