ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC— 510(k) K952361

Name: FDA 510(k) clearance K952361
Creator: U.S. Food and Drug Administration
Published: 1995-10-26

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K952361 for ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC, Substantially Equivalent on 1995-10-26. 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: 1995-05-08
Decision date: 1995-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monmouth Junction, NJ, US

Download summary PDF View on FDA.gov ↗

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