ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/— 510(k) K990786

Name: FDA 510(k) clearance K990786
Creator: U.S. Food and Drug Administration
Published: 1999-03-26

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K990786 for ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/, Substantially Equivalent on 1999-03-26. 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: 1999-03-10
Decision date: 1999-03-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Monmouth Junction, NJ, US

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