# Princeton BioMeditech Corp.

- Location (FDA's records): Monmouth Junction, NJ
- FDA decisions: 72 (1994–2025): 72 510(k) clearances
- Product codes: DIO (7), DIS (6), JHI (5), PSZ (4), GTY (4), DJG (4), JXM (4), DKE (4), DKZ (3), LDJ (3), MMI (3), LAG (3)
- Predicates its devices cite: 22 (13 its own); citations of its devices by later devices: 22 (13 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Genosis, Ltd.: 2 (https://510kreport.com/company/genosis)
- Embryotech Laboratories, Inc.: 2 (https://510kreport.com/company/embryotech-laboratories)
- OraSure Technologies, Inc.: 1 (https://510kreport.com/company/orasure-technologies)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)
- Healgen: 1 (https://510kreport.com/company/healgen)
- Medtox Diagnostics, Inc.: 1 (https://510kreport.com/company/medtox-diagnostics)

## Firms that cite its devices most
- ACON Laboratories, Inc.: 6 (https://510kreport.com/company/acon-laboratories)
- Sandstone Diagnostics, Inc.: 1 (https://510kreport.com/company/sandstone-diagnostics)
- Guangzhou Wondfo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Medical Electronic Systems, Ltd.: 1 (https://510kreport.com/company/medical-electronic-systems)

## Its most-cited devices
- K990786: Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/Opi/Coc/THC/PCP/Bzo/Bar/MTD/Tca/Amp, Biosign DOA10, Biosign Met/Opi/ (1999), cited by 5
- K100341: Spermcheck Fertility (2010), cited by 2
- K132465: Biosign Flu a + B, Status Flu a & B (2013), cited by 1
- K040708: Status First Strep a (2004), cited by 1
- K961249: Accusign Met/Biosign Met (1996), cited by 1
- K991080: Accusign MTD, Biosign MTD (1999), cited by 1

## Recent decisions
- K251538: Status™ COVID-19/Flu A&B (Nov 14, 2025)
- K182157: BioSign Flu A+B (Sep 18, 2018)
- K130650: Status DS Oxy (Feb 26, 2014)
- K133474: Biosign Flu a + B, Status Flu a & B (Dec 10, 2013)
- K132465: Biosign Flu a + B, Status Flu a & B (Sep 9, 2013)
- K083746: Biosign Flu a+B (Nov 10, 2010)
- K100817: Biosign Ifobtest, Biosign Fecal Occult Blood Test (Jul 1, 2010)
- K100341: Spermcheck Fertility (May 4, 2010)

Source page: https://510kreport.com/company/princeton-biomeditech