Data / Medical devices / United States / Princeton Biomeditech Corp.
Princeton Biomeditech Corp.: FDA-registered device maker in Monmouth Jct, NJ, United States, 62 510(k) clearances
Princeton Biomeditech Corp. is registered with the FDA (registration 2246703) in Monmouth Jct, NJ, United States. It lists 43 device types. The FDA files 62 510(k) clearances under its listings, the newest dated November 14, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2246703
- Address
- 4242 U.S. Hwy. 1, Monmouth Jct, NJ, United States, 08852
- Owner or operator
- PRINCETON BIOMEDITECH CORP. (2246703)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- October 8, 1992
- Registered through
- 2026
- Brand names listed
- ACCUSIGN DOA 10 Panel, ACCUSIGN OPI, AccuSign AMP, AccuSign BAR, AccuSign BZO, AccuSign COC, AccuSign DOA 10, AccuSign DOA 2 COC/THC and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 14, 2025 | K251538 | Status COVID-19/Flu A&B | SCA | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| February 26, 2014 | K130650 | STATUS DS OXY | DJG | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| December 10, 2013 | K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | PSZ | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| September 9, 2013 | K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | PSZ | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| November 10, 2010 | K083746 | BIOSIGN FLU A+B | PSZ | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| July 1, 2010 | K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | KHE | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| May 4, 2010 | K100341 | SPERMCHECK FERTILITY | POV | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| October 6, 2008 | K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | GTY | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| January 24, 2008 | K073039 | SPERMCHECK VASECTOMY | POV | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| November 26, 2007 | K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP | LAG | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| February 20, 2007 | K062565 | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | MKU | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| January 23, 2006 | K050955 | LIFESIGN DXPRESS, MODEL LSR2000 | JHI | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| November 22, 2004 | K040708 | STATUS FIRST STREP A | GTY | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| October 8, 2002 | K022946 | LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST | MMI | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| June 10, 2002 | K014069 | LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC | DIO | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| June 10, 2002 | K014067 | LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC | DIO | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| June 10, 2002 | K014066 | LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC | LDJ | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| May 23, 2002 | K020439 | STATUS HCG SERUM/URINE | JHI | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| May 23, 2002 | K014193 | LIFESIGN DOA 4 (THC/OPI/COC/MET) | LDJ | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| May 23, 2002 | K014192 | LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET | MVO | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| July 6, 1999 | K992068 | STATUS STIK, ACCUSIGN STIK | DKE | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| May 28, 1999 | K991299 | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI | JHT | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| April 15, 1999 | K991082 | ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO | DIS | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| April 15, 1999 | K991080 | ACCUSIGN MTD, BIOSIGN MTD | DJR | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| April 15, 1999 | K991079 | ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO | JXM | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| April 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 | DKE | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| April 15, 1999 | K991018 | ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR | DIS | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| March 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/ | LAG | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| December 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/ | LAG | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| November 25, 1998 | K983386 | BIOSTREP A-DIRECT STREP A ANTIGEN TEST | GTY | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| September 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 | DKE | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| September 22, 1998 | K980798 | BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST | LYR | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| August 25, 1998 | K981801 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | LFH | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| July 6, 1998 | K981882 | CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST | MMI | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| June 12, 1998 | K981771 | ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP | DJG | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| March 13, 1998 | K980249 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | LFG | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| December 24, 1997 | K974425 | BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST | DHA | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| July 7, 1997 | K971349 | BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST | GTY | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| February 4, 1997 | K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB | KTN | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| November 29, 1996 | K963693 | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST | CEP | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| November 7, 1996 | K963513 | CARDIAC STATUS TROPONIN I | MMI | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| August 30, 1996 | K962672 | ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY | JXM | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| August 19, 1996 | K962353 | ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) | DIO | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| August 15, 1996 | K962673 | ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY | DJR | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| August 15, 1996 | K962669 | ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY | DIS | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| May 31, 1996 | K961266 | ACCUSIGN, BIOSIGN PCP | LCM | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| April 25, 1996 | K961249 | ACCUSIGN MET/BIOSIGN MET | LAF | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| November 3, 1995 | K954571 | ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI | DIO | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| October 26, 1995 | K952361 | ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC | DIO | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| October 26, 1995 | K945549 | ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET | DIO | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| August 14, 1995 | K952360 | CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN | DDR | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| April 13, 1995 | K945610 | ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP | DKZ | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| March 1, 1995 | K950307 | BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST | DHA | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| February 22, 1995 | K945609 | ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC | DIO | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| February 22, 1995 | K945550 | ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC | LDJ | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| February 22, 1995 | K943439 | ABUSIGN DOA4 | DKZ | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| February 10, 1995 | K945608 | ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI | DJG | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| February 10, 1995 | K945514 | LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG | LCX | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| October 25, 1994 | K944426 | BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE | JHI | Substantially Equivalent | Princeton BioMeditech Corp. | accessdata.fda.gov |
| July 12, 1994 | K925355 | BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST | LFX | Substantially Equivalent | Princeton Biomedix | accessdata.fda.gov |
| March 4, 1993 | K930185 | OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP | CEP | Substantially Equivalent | Princeton Biomedix | accessdata.fda.gov |
| January 26, 1993 | K926308 | LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST | LCX | Substantially Equivalent | Princeton Biomedix | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 23, 2024 | 95439 | Class II | Ongoing | 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 | This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantita | accessdata.fda.gov |
| March 9, 2012 | 62537 | Class II | Terminated | 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 type B nucleoprotein | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. | accessdata.fda.gov |
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Updated November 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.