Pan Probe Biotech, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Pan Probe Biotech, Inc.” (first 2001, latest 2002), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 14 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent Pan Probe Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020968 | LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD | JHI | 2002-07-15 | 111 |
| K013796 | LIVESURE METHADONE SCREEN TESTS | DJR | 2001-11-26 | 11 |
| K012133 | LIVESURE BARBITURATES SCREEN TEST | DIS | 2001-07-20 | 11 |
| K012131 | LIVESURE BENZODIAZEPINES SCREEN TESTS | JXM | 2001-07-20 | 11 |
| K012107 | LIVESURE PHENECYCLINE (PCP) SCREEN TESTS | LCM | 2001-07-20 | 15 |
| K011610 | LIVESURE METHAMPHETAMINE SCREEN TESTS | LAF | 2001-06-08 | 14 |
| K011609 | LIVESURE AMPHETAMINE SCREEN TEST | DKZ | 2001-06-08 | 14 |
| K010967 | LIVESURE COCAINE SCREEN TEST | DIO | 2001-04-17 | 15 |
| K011011 | LIVESURE MORPHINE SCREEN TEST | DOE | 2001-04-13 | 9 |
| K010001 | LIVESURE THC SCREEN TEST | LDJ | 2001-02-05 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Pan Probe Biotech, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pan Probe Biotech, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Pan Probe Biotech, Inc.” (first 2001, latest 2002), across 10 product codes in 2 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 Pan Probe Biotech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pan Probe Biotech, Inc. is 14 days.
Which FDA product codes appear under Pan Probe Biotech, Inc.?
The most frequent FDA product codes under this applicant name are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); DIS (Enzyme Immunoassay, Barbiturate, 1); DJR (Enzyme Immunoassay, Methadone, 1).
Next steps
- See all 10 Pan Probe Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIO, Pan Probe Biotech, Inc.'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.