DeviceClearance

BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB— 510(k) K961024

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K961024 for BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB, Substantially Equivalent on 1997-02-04. Applicant: Princeton BioMeditech Corp..

Clearance details

Applicant
Princeton BioMeditech Corp.
Product code
Code KTN
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Monmouth Junction, NJ, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.