ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP— 510(k) K945610

Name: FDA 510(k) clearance K945610
Creator: U.S. Food and Drug Administration
Published: 1995-04-13

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K945610 for ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP, Substantially Equivalent on 1995-04-13. Applicant: Princeton BioMeditech Corp.. Device class: 2.

Clearance details

Applicant: Princeton BioMeditech Corp.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1994-11-15
Decision date: 1995-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DKZ

view all

K240670 — DRI Ecstasy Plus Assay2024-10-30
K233019 — AllTest Multi-Drug Rapid Test Cup +3 more2023-12-13
K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard2023-05-19
K200363 — Quidel Triage® TOX Drug Screen, 946002020-03-11
K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel2019-10-03

More clearances from Princeton BioMeditech Corp.

view all

K251538 — Status COVID-19/Flu A&B2025-11-14
K182157 — BioSign Flu A+B2018-09-18
K130650 — STATUS DS OXY2014-02-26
K133474 — BIOSIGN FLU A + B, STATUS FLU A & B2013-12-10
K132465 — BIOSIGN FLU A + B, STATUS FLU A & B2013-09-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.