Medical Device Manufacturer · US , Monmouth Junction , NJ

Princeton BioMeditech Corp.

72 submissions · 72 cleared · Since 1994
72
Total
72
Cleared
0
Denied

Princeton BioMeditech Corp. — FDA 510(k) Submissions

Princeton BioMeditech Corp. has submitted 72 FDA 510(k) premarket notifications since 1994, of which 72 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Cocaine And Cocaine Metabolites, Enzyme Immunoassay, Barbiturate, Visual, Pregnancy Hcg, Prescription Use, Enzyme Immunoassay, Opiates, Reagents, Test, Tetrahydrocannabinol . Use the specialty filter in the sidebar to narrow results.

72 devices
1–25 of 72
Status? COVID-19/Flu A&B
K251538 · SCA Multi-analyte Respiratory... · Microbiology
Nov 2025 179d
BioSign Flu A+B
K182157 · PSZ Devices Detecting... · Microbiology
Sep 2018 40d
STATUS DS OXY
K130650 · DJG Enzyme Immunoassay, Opiates · Toxicology
Feb 2014 352d
BIOSIGN FLU A + B, STATUS FLU A & B
K133474 · PSZ Devices Detecting... · Microbiology
Dec 2013 28d
BIOSIGN FLU A + B, STATUS FLU A & B
K132465 · PSZ Devices Detecting... · Microbiology
Sep 2013 33d
BIOSIGN FLU A+B
K083746 · PSZ Devices Detecting... · Microbiology
Nov 2010 693d
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
K100817 · KHE Reagent, Occult Blood · Hematology
Jul 2010 104d
SPERMCHECK FERTILITY
K100341 · POV Semen Analysis Device · Hematology
May 2010 88d
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
K082661 · GTY Antigens, All Groups,... · Microbiology
Oct 2008 24d
SPERMCHECK VASECTOMY
K073039 · POV Semen Analysis Device · Hematology
Jan 2008 87d
MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP
K062575 · LAG High Pressure Liquid... · Toxicology
Nov 2007 452d
STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
K062565 · MKU Enzyme Immunoassay,... · Chemistry
Feb 2007 173d
LIFESIGN DXPRESS, MODEL LSR2000
K050955 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jan 2006 283d
STATUS FIRST STREP A
K040708 · GTY Antigens, All Groups,... · Microbiology
Nov 2004 249d
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
K023837 · LAF Gas Chromatography,... · Toxicology
Sep 2003 301d
LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
K022946 · MMI Immunoassay Method,... · Chemistry
Oct 2002 34d
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
K014066 · LDJ Enzyme Immunoassay,... · Toxicology
Jun 2002 182d
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC
K014067 · DIO Enzyme Immunoassay,... · Toxicology
Jun 2002 182d
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
K014069 · DIO Enzyme Immunoassay,... · Toxicology
Jun 2002 182d
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET
K014192 · MVO Kit, Test, Multiple,... · Toxicology
May 2002 153d
LIFESIGN DOA 4 (THC/OPI/COC/MET)
K014193 · LDJ Enzyme Immunoassay,... · Toxicology
May 2002 153d
STATUS HCG SERUM/URINE
K020439 · JHI Visual, Pregnancy Hcg,... · Chemistry
May 2002 101d
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
K001225 · DKZ Enzyme Immunoassay,... · Toxicology
May 2000 30d
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000
K992422 · DJG Enzyme Immunoassay, Opiates · Toxicology
Aug 1999 20d
STATUS STIK, ACCUSIGN STIK
K992068 · DKE Reagents, Test,... · Toxicology
Jul 1999 18d
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