ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)— 510(k) K962353

Name: FDA 510(k) clearance K962353
Creator: U.S. Food and Drug Administration
Published: 1996-08-19

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K962353 for ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP), Substantially Equivalent on 1996-08-19. Applicant: Princeton BioMeditech Corp.. Device class: 2.

Clearance details

Applicant: Princeton BioMeditech Corp.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1996-06-18
Decision date: 1996-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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