Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Princeton BioMeditech Corp. · Predicate Candidate Screening
72 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
249 days90th percentile
72clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251538 | Status™ COVID-19/Flu A&B | Princeton BioMeditech Corp. | 2025-11-14 | 179 | 0 |
| K182157 | BioSign Flu A+B | Princeton BioMeditech Corp. | 2018-09-18 | 40 | 0 |
| K130650 | STATUS DS OXY | Princeton BioMeditech Corp. | 2014-02-26 | 352 | 0 |
| K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | Princeton BioMeditech Corp. | 2013-12-10 | 28 | 0 |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | Princeton BioMeditech Corp. | 2013-09-09 | 33 | 0 |
| K083746 | BIOSIGN FLU A+B | Princeton BioMeditech Corp. | 2010-11-10 | 693 | 3 |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Princeton BioMeditech Corp. | 2010-07-01 | 104 | 0 |
| K100341 | SPERMCHECK FERTILITY | Princeton BioMeditech Corp. | 2010-05-04 | 88 | 0 |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | Princeton BioMeditech Corp. | 2008-10-06 | 24 | 0 |
| K073039 | SPERMCHECK VASECTOMY | Princeton BioMeditech Corp. | 2008-01-24 | 87 | 0 |
| K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO | Princeton BioMeditech Corp. | 2007-11-26 | 452 | 0 |
| K062565 | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | Princeton BioMeditech Corp. | 2007-02-20 | 173 | 0 |
| K050955 | LIFESIGN DXPRESS, MODEL LSR2000 | Princeton BioMeditech Corp. | 2006-01-23 | 283 | 0 |
| K040708 | STATUS FIRST STREP A | Princeton BioMeditech Corp. | 2004-11-22 | 249 | 0 |
| K023837 | LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDM | Princeton BioMeditech Corp. | 2003-09-15 | 301 | 0 |
| K022946 | LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST | Princeton BioMeditech Corp. | 2002-10-08 | 34 | 0 |
| K014067 | LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), | Princeton BioMeditech Corp. | 2002-06-10 | 182 | 0 |
| K014066 | LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN M | Princeton BioMeditech Corp. | 2002-06-10 | 182 | 0 |
| K014069 | LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK C | Princeton BioMeditech Corp. | 2002-06-10 | 182 | 0 |
| K020439 | STATUS HCG SERUM/URINE | Princeton BioMeditech Corp. | 2002-05-23 | 101 | 0 |
| K014192 | LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK M | Princeton BioMeditech Corp. | 2002-05-23 | 153 | 0 |
| K014193 | LIFESIGN DOA 4 (THC/OPI/COC/MET) | Princeton BioMeditech Corp. | 2002-05-23 | 153 | 0 |
| K001225 | ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA R | Princeton BioMeditech Corp. | 2000-05-17 | 30 | 0 |
| K992422 | ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/T | Princeton BioMeditech Corp. | 1999-08-10 | 20 | 0 |
| K992068 | STATUS STIK, ACCUSIGN STIK | Princeton BioMeditech Corp. | 1999-07-06 | 18 | 0 |
| K991751 | STATUS CUP ACCUSIGN CUP | Princeton BioMeditech Corp. | 1999-06-18 | 25 | 0 |
| K991299 | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STE | Princeton BioMeditech Corp. | 1999-05-28 | 52 | 0 |
| K991080 | ACCUSIGN MTD, BIOSIGN MTD | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K991018 | ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K991079 | ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K991076 | ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K991082 | ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS D | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K991084 | ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/B | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K991078 | ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K990786 | ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/ | Princeton BioMeditech Corp. | 1999-03-26 | 16 | 0 |
| K983501 | ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/ | Princeton BioMeditech Corp. | 1998-12-18 | 73 | 0 |
| K983386 | BIOSTREP A-DIRECT STREP A ANTIGEN TEST | Princeton BioMeditech Corp. | 1998-11-25 | 60 | 0 |
| K983147 | ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/A | Princeton BioMeditech Corp. | 1998-09-28 | 20 | 0 |
| K980798 | BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TE | Princeton BioMeditech Corp. | 1998-09-22 | 204 | 1 |
| K981801 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | Princeton BioMeditech Corp. | 1998-08-25 | 96 | 0 |
| K981444 | BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE S | Princeton BioMeditech Corp. | 1998-07-22 | 91 | 0 |
| K981882 | CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST | Princeton BioMeditech Corp. | 1998-07-06 | 39 | 0 |
| K981443 | BIOSIGN HCG I - ONE STEP PREGNANCY TEST | Princeton BioMeditech Corp. | 1998-06-25 | 64 | 0 |
| K981771 | ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP | Princeton BioMeditech Corp. | 1998-06-12 | 24 | 0 |
| K980249 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | Princeton BioMeditech Corp. | 1998-03-13 | 49 | 0 |
| K974425 | BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP P | Princeton BioMeditech Corp. | 1997-12-24 | 30 | 0 |
| K974181 | ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA | Princeton BioMeditech Corp. | 1997-12-11 | 35 | 0 |
| K971349 | BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST | Princeton BioMeditech Corp. | 1997-07-07 | 88 | 0 |
| K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN M | Princeton BioMeditech Corp. | 1997-02-04 | 327 | 0 |
| K963693 | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST | Princeton BioMeditech Corp. | 1996-11-29 | 74 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda