Biophor Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Biophor Diagnostics, Inc.” (first 2013, latest 2015), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 324 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 |
|---|---|---|
| 2013 | 2 | 168 |
| 2014 | 2 | 252 |
| 2015 | 3 | 354 |
| 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 |
|---|---|---|---|
| LAF | Gas Chromatography, Methamphetamine | 2 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent Biophor Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls | LAF | 2015-09-18 | 396 |
| K142129 | RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET | DIO | 2015-07-24 | 354 |
| K141748 | RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET | DKZ | 2015-05-20 | 324 |
| K133047 | RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU | LAF | 2014-12-18 | 447 |
| K133642 | RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK | DJG | 2014-01-24 | 58 |
| K132096 | RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR | LDJ | 2013-10-18 | 102 |
| K122703 | RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR | LCM | 2013-04-25 | 233 |
Recalls
openFDA lists no recalls under a recalling firm named Biophor Diagnostics, 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 Biophor Diagnostics, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Biophor Diagnostics, Inc.” (first 2013, latest 2015), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biophor Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biophor Diagnostics, Inc. is 324 days.
Which FDA product codes appear under Biophor Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are LAF (Gas Chromatography, Methamphetamine, 2); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1); DJG (Enzyme Immunoassay, Opiates, 1).
Next steps
- See all 7 Biophor Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LAF, Biophor Diagnostics, 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.