Princeton Biomedix: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Princeton Biomedix” (first 1976, latest 1995), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CJR | Acid Phosphatase, Thymol Blue Monophosphate | 1 | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 1 | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Chemistry (11)
- Microbiology (2)
- Immunology (1)
Most recent Princeton Biomedix 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942052 | LIFESIGN MI MYOGLOBIN | DDR | 1995-02-07 | 285 |
| K925355 | BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST | LFX | 1994-07-12 | 628 |
| K930185 | OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP | CEP | 1993-03-04 | 49 |
| K925183 | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST | KTN | 1993-02-23 | 132 |
| K926308 | LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST | LCX | 1993-01-26 | 42 |
| K901011 | BIOSIGN HCG-ONE STEP PREGNANCY TEST | JHI | 1990-05-04 | 60 |
| K894750 | BIOSTIX I. HCG - ONE STEP PREGNANCY TEST | JHI | 1989-10-18 | 84 |
| K894705 | BIOSPOT HCG-RAPID PREGNANCY TEST | JHI | 1989-10-18 | 85 |
| K892654 | BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST | DHA | 1989-06-19 | 67 |
| K761315 | ALKALINE PHOSPHATASE (ALP)/PNPP | CJE | 1977-02-24 | 63 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Princeton Biomedix.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Princeton BioMeditech Corp. (72 510(k)s)
- Princeton Regulatory Assoc. (4 510(k)s)
- Princeton Applied Research Corp. (2 510(k)s)
- Princeton Medical Instruments, Inc. (2 510(k)s)
- Princeton Electronic Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Princeton Biomedix?
FDA lists 14 510(k) clearances under the applicant name “Princeton Biomedix” (first 1976, latest 1995), across 12 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Princeton Biomedix?
The median time from FDA receipt to decision across 510(k)s cleared under the name Princeton Biomedix is 76 days.
Which FDA product codes appear under Princeton Biomedix?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 3); CEP (Radioimmunoassay, Luteinizing Hormone, 1); CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, 1).
Next steps
- See all 14 Princeton Biomedix clearances with predicates and recalls
- Run predicate analysis for product code JHI, Princeton Biomedix's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.