ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8— 510(k) K991078

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K991078 for ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8, Substantially Equivalent on 1999-04-15. Applicant: Princeton BioMeditech Corp.. Device class: 2.

Clearance details

Applicant
Princeton BioMeditech Corp.
Product code
Code DKE
Device class
Class 2
Regulation
21 CFR 862.3870
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Monmouth Junction, NJ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DKE

view all

More clearances from Princeton BioMeditech Corp.

view all

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