MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP— 510(k) K062575

Name: FDA 510(k) clearance K062575
Creator: U.S. Food and Drug Administration
Published: 2007-11-26

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K062575 for MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, Substantially Equivalent on 2007-11-26. Applicant: Princeton BioMeditech Corp.. Device class: 2.

Clearance details

Applicant: Princeton BioMeditech Corp.
Product code: Code LAG
Device class: Class 2
Regulation: 21 CFR 862.3610
Advisory panel: Clinical Toxicology
Date received: 2006-08-31
Decision date: 2007-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monmouth Junction, NJ, US

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