Biorent Diagnostic, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Biorent Diagnostic, Inc.” (first 1981, latest 1983), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 27 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 |
|---|---|---|---|
| CDO | Acid, Uric, Uricase (U.V.) | 1 | 1 |
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (10)
- Hematology (1)
Most recent Biorent Diagnostic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832747 | ALBUMIN REAGENT SET | CIX | 1983-10-14 | 60 |
| K823211 | CK-UV REAGENT | JHS | 1982-11-22 | 25 |
| K823060 | HEMOGLOBIN REAGENT | KHG | 1982-11-22 | 35 |
| K822494 | OPTIMIZED UV-GPT REAGENT SET | CKA | 1982-09-21 | 34 |
| K822493 | OPTIMIZED UV-GOT REAGENT SET | CIT | 1982-09-21 | 34 |
| K822492 | OPTIMIZED UV-LDH REAGENT SET | CFJ | 1982-09-17 | 30 |
| K820768 | COLORIMETRIC LDH REAGENT SET | CFH | 1982-04-14 | 23 |
| K820632 | COLORIMETRIC URIC ACID REAGENT SET | KNK | 1982-03-25 | 17 |
| K813555 | GLUCOSE ENZYME-COLOR REAGENT SET | CGA | 1982-01-18 | 27 |
| K813244 | UV URIC ACID DETERMINATION | CDO | 1981-12-08 | 20 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biorent Diagnostic, 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 Biorent Diagnostic, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Biorent Diagnostic, Inc.” (first 1981, latest 1983), across 11 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 Biorent Diagnostic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biorent Diagnostic, Inc. is 27 days.
Which FDA product codes appear under Biorent Diagnostic, Inc.?
The most frequent FDA product codes under this applicant name are CDO (Acid, Uric, Uricase (U.V.), 1); CFH (Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase, 1); CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, 1).
Next steps
- See all 11 Biorent Diagnostic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDO, Biorent Diagnostic, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.