510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K945610Substantially Equivalent

Abusign(tm) Amp, Doa-Amp, Accusign(tm) Amp-Doa-Amp, Biosign(tm) Amp, Doa-Amp

Princeton BioMeditech Corp., Princeton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945610 is the FDA 510(k) clearance record for ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP, a class II device, cleared for Princeton BioMeditech Corp. on under FDA product code DKZ (Enzyme Immunoassay, Amphetamine). FDA records list 72 510(k) clearances for Princeton BioMeditech Corp., from to . As of , FDA records show no recalls naming K945610.

Clearance record

Decision date
Received
(149 days to decision)
Product code
DKZ Enzyme Immunoassay, Amphetamine
Regulation
21 CFR 862.3100
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Princeton BioMeditech Corp. P.O. Box 7139, Princeton NJ
510(k) summary
Statement
Third party review
No

Clearances, product code DKZ

Trailing 12 months

FDA records hold no clearances under product code DKZ in the trailing twelve months.

FDA records show no clearances under product code DKZ in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DKZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260