Princeton Biomeditech Corp
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 72
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0259-2025 | Class II | Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotr | August 23, 2024 |
| Z-2307-2012 | Class II | Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY | March 9, 2012 |
| Z-2308-2012 | Class II | Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 0 | March 9, 2012 |
| Z-2306-2012 | Class II | Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. | March 9, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251538 | Status COVID-19/Flu A&B | November 14, 2025 |
| K182157 | BioSign Flu A+B | September 18, 2018 |
| K130650 | STATUS DS OXY | February 26, 2014 |
| K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | December 10, 2013 |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | September 9, 2013 |
| K083746 | BIOSIGN FLU A+B | November 10, 2010 |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | July 1, 2010 |
| K100341 | SPERMCHECK FERTILITY | May 4, 2010 |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | October 6, 2008 |
| K073039 | SPERMCHECK VASECTOMY | January 24, 2008 |
| K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP | November 26, 2007 |
| K062565 | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | February 20, 2007 |
| K050955 | LIFESIGN DXPRESS, MODEL LSR2000 | January 23, 2006 |
| K040708 | STATUS FIRST STREP A | November 22, 2004 |
| K023837 | LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK ME | September 15, 2003 |
| K022946 | LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST | October 8, 2002 |
| K014067 | LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/C | June 10, 2002 |
| K014069 | LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC | June 10, 2002 |
| K014066 | LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC | June 10, 2002 |
| K014193 | LIFESIGN DOA 4 (THC/OPI/COC/MET) | May 23, 2002 |