Company · US
Princeton BioMeditech Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2025. Name variants (Inc, Corp, punctuation) are merged.
72510(k) clearances (1 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 7 |
| DIS | Enzyme Immunoassay, Barbiturate | 6 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 6 |
| DJG | Enzyme Immunoassay, Opiates | 4 |
| DKE | Reagents, Test, Tetrahydrocannabinol | 4 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 4 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 4 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 4 |
| DKZ | Enzyme Immunoassay, Amphetamine | 3 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 3 |
| LAG | High Pressure Liquid Chromatography, Methamphetamine | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 |
| MMI | Immunoassay Method, Troponin Subunit | 3 |
| DHA | System, Test, Human Chorionic Gonadotropin | 2 |
| DJR | Enzyme Immunoassay, Methadone | 2 |
| LAF | Gas Chromatography, Methamphetamine | 2 |
| POV | Semen Analysis Device | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 14, 2025 | K251538 | Status COVID-19/Flu A&B Princeton BioMeditech Corp. | SCA |
| Sep 18, 2018 | K182157 | BioSign Flu A+B Princeton BioMeditech Corp. | PSZ |
| Feb 26, 2014 | K130650 | STATUS DS OXY Princeton BioMeditech Corp. | DJG |
| Dec 10, 2013 | K133474 | BIOSIGN FLU A + B, STATUS FLU A & B Princeton BioMeditech Corp. | PSZ |
| Sep 9, 2013 | K132465 | BIOSIGN FLU A + B, STATUS FLU A & B Princeton BioMeditech Corp. | PSZ |
| Nov 10, 2010 | K083746 | BIOSIGN FLU A+B Princeton BioMeditech Corp. | PSZ |
| Jul 1, 2010 | K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST Princeton BioMeditech Corp. | KHE |
| May 4, 2010 | K100341 | SPERMCHECK FERTILITY Princeton BioMeditech Corp. | POV |
| Oct 6, 2008 | K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A Princeton BioMeditech Corp. | GTY |
| Jan 24, 2008 | K073039 | SPERMCHECK VASECTOMY Princeton BioMeditech Corp. | POV |
| Nov 26, 2007 | K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP Princeton BioMeditech Corp. | LAG |
| Feb 20, 2007 | K062565 | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE Princeton BioMeditech Corp. | MKU |
| Jan 23, 2006 | K050955 | LIFESIGN DXPRESS, MODEL LSR2000 Princeton BioMeditech Corp. | JHI |
| Nov 22, 2004 | K040708 | STATUS FIRST STREP A Princeton BioMeditech Corp. | GTY |
| Sep 15, 2003 | K023837 | LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA Princeton BioMeditech Corp. | LAF |
| Oct 8, 2002 | K022946 | LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST Princeton BioMeditech Corp. | MMI |
| Jun 10, 2002 | K014069 | LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC Princeton BioMeditech Corp. | DIO |
| Jun 10, 2002 | K014067 | LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC Princeton BioMeditech Corp. | DIO |
| Jun 10, 2002 | K014066 | LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC Princeton BioMeditech Corp. | LDJ |
| May 23, 2002 | K020439 | STATUS HCG SERUM/URINE Princeton BioMeditech Corp. | JHI |
| May 23, 2002 | K014193 | LIFESIGN DOA 4 (THC/OPI/COC/MET) Princeton BioMeditech Corp. | LDJ |
| May 23, 2002 | K014192 | LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET Princeton BioMeditech Corp. | MVO |
| May 17, 2000 | K001225 | ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. Princeton BioMeditech Corp. | DKZ |
| Aug 10, 1999 | K992422 | ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 Princeton BioMeditech Corp. | DJG |
| Jul 6, 1999 | K992068 | STATUS STIK, ACCUSIGN STIK Princeton BioMeditech Corp. | DKE |
| Jun 18, 1999 | K991751 | STATUS CUP ACCUSIGN CUP Princeton BioMeditech Corp. | DKE |
| May 28, 1999 | K991299 | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI Princeton BioMeditech Corp. | JHT |
| Apr 15, 1999 | K991084 | ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD Princeton BioMeditech Corp. | DIS |
| Apr 15, 1999 | K991082 | ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO Princeton BioMeditech Corp. | DIS |
| Apr 15, 1999 | K991080 | ACCUSIGN MTD, BIOSIGN MTD Princeton BioMeditech Corp. | DJR |
| Apr 15, 1999 | K991079 | ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO Princeton BioMeditech Corp. | JXM |
| Apr 15, 1999 | K991078 | ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8 Princeton BioMeditech Corp. | DKE |
| Apr 15, 1999 | K991076 | ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP Princeton BioMeditech Corp. | DIS |
| Apr 15, 1999 | K991018 | ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR Princeton BioMeditech Corp. | DIS |
| Mar 26, 1999 | K990786 | ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ Princeton BioMeditech Corp. | LAG |
| Dec 18, 1998 | K983501 | ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/ Princeton BioMeditech Corp. | LAG |
| Nov 25, 1998 | K983386 | BIOSTREP A-DIRECT STREP A ANTIGEN TEST Princeton BioMeditech Corp. | GTY |
| Sep 28, 1998 | K983147 | ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P Princeton BioMeditech Corp. | DKE |
| Sep 22, 1998 | K980798 | BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST Princeton BioMeditech Corp. | LYR |
| Aug 25, 1998 | K981801 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA Princeton BioMeditech Corp. | LFH |
| Jul 22, 1998 | K981444 | BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP Princeton BioMeditech Corp. | JHI |
| Jul 6, 1998 | K981882 | CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST Princeton BioMeditech Corp. | MMI |
| Jun 25, 1998 | K981443 | BIOSIGN HCG I - ONE STEP PREGNANCY TEST Princeton BioMeditech Corp. | JHI |
| Jun 12, 1998 | K981771 | ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP Princeton BioMeditech Corp. | DJG |
| Mar 13, 1998 | K980249 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA Princeton BioMeditech Corp. | LFG |
| Dec 24, 1997 | K974425 | BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST Princeton BioMeditech Corp. | DHA |
| Dec 11, 1997 | K974181 | ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B Princeton BioMeditech Corp. | JXM |
| Jul 7, 1997 | K971349 | BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST Princeton BioMeditech Corp. | GTY |
| Feb 4, 1997 | K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB Princeton BioMeditech Corp. | KTN |
| Nov 29, 1996 | K963693 | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST Princeton BioMeditech Corp. | CEP |
Newest 50 of 72.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2024 | Princeton Biomeditech Corp Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy.
Model/Catalog Number: 1004 Open, Classified |
JHI | K944426 |
| Aug 31, 2012 | Princeton Biomeditech Corp Status Flu A + B Test
Manufactured by
Princeton Bio Meditech Corporation
Monmouth Junction, NJ 08852 USA.
The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type Terminated |
GNX | K083746 |
| Aug 31, 2012 | Princeton Biomeditech Corp Poly stat Flu A & B Test
Manufactured for
Polymedco
510 Furnace Dock Road
Cortlandt Manor, NY 10567
Tel 800-431-2123
914-739-5400
Fax 914-739-5890.
The BioSign Flu A + B test is an in vitro Terminated |
GNX | K083746 |
| Aug 31, 2012 | Princeton Biomeditech Corp Orasure QuickFlu Rapid A+B Test
Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA.
The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and Terminated |
GNX | K083746 |