Princeton BioMeditech Corp.: FDA clearances and approvals
Princeton BioMeditech Corp. has 72 FDA 510(k) clearances (first 1994, latest 2025), across 30 product codes in 5 review panels. Median 510(k) review time: 65 days. openFDA lists 4 product recalls by a recalling firm named Princeton BioMeditech Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 30 |
| 2014 | 1 | 352 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 40 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 179 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Princeton BioMeditech Corp.'s cleared 510(k)s took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 157 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 7 | 7 |
| DIS | Enzyme Immunoassay, Barbiturate | 6 | 6 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 | 5 |
| DJG | Enzyme Immunoassay, Opiates | 4 | 4 |
| DKE | Reagents, Test, Tetrahydrocannabinol | 4 | 4 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 4 | 4 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 4 | 4 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 4 | 4 |
| DKZ | Enzyme Immunoassay, Amphetamine | 3 | 3 |
| LAG | High Pressure Liquid Chromatography, Methamphetamine | 3 | 3 |
Plus 20 more product codes.
Review panels
- Clinical Toxicology (43)
- Clinical Chemistry (14)
- Microbiology (11)
- Hematology (3)
- Immunology (1)
Most recent Princeton BioMeditech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251538 | Status COVID-19/Flu A&B | SCA | 2025-11-14 | 179 |
| K182157 | BioSign Flu A+B | PSZ | 2018-09-18 | 40 |
| K130650 | STATUS DS OXY | DJG | 2014-02-26 | 352 |
| K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | PSZ | 2013-12-10 | 28 |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | PSZ | 2013-09-09 | 33 |
| K083746 | BIOSIGN FLU A+B | PSZ | 2010-11-10 | 693 |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | KHE | 2010-07-01 | 104 |
| K100341 | SPERMCHECK FERTILITY | POV | 2010-05-04 | 88 |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | GTY | 2008-10-06 | 24 |
| K073039 | SPERMCHECK VASECTOMY | POV | 2008-01-24 | 87 |
62 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2024-08-23.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Princeton BioMeditech Corp.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Princeton BioMeditech Corp. have?
Princeton BioMeditech Corp. has 72 FDA 510(k) clearances (first 1994, latest 2025), across 30 product codes in 5 review panels.
How long does FDA take to clear Princeton BioMeditech Corp.'s 510(k)s?
The median time from FDA receipt to decision across Princeton BioMeditech Corp.'s cleared 510(k)s is 65 days.
What devices does Princeton BioMeditech Corp. make?
Its most frequent FDA product codes are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 7); DIS (Enzyme Immunoassay, Barbiturate, 6); JHI (Visual, Pregnancy Hcg, Prescription Use, 5).
Has Princeton BioMeditech Corp. had device recalls?
openFDA lists 4 product recalls in 2 recall events by a recalling firm whose name matches Princeton BioMeditech Corp; the most recent began 2024-08-23. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 72 Princeton BioMeditech Corp. clearances with predicates and recalls
- Run predicate analysis for product code DIO, Princeton BioMeditech Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.