ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P— 510(k) K983147

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K983147 for ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P, Substantially Equivalent on 1998-09-28. 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
Traditional
Location
Princeton, NJ, US
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