ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000— 510(k) K992422

Name: FDA 510(k) clearance K992422
Creator: U.S. Food and Drug Administration
Published: 1999-08-10

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K992422 for ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000, Substantially Equivalent on 1999-08-10. Applicant: Princeton BioMeditech Corp.. Device class: 2.

Clearance details

Applicant: Princeton BioMeditech Corp.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1999-07-21
Decision date: 1999-08-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Monmouth Junction, NJ, US

Download summary PDF View on FDA.gov ↗

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