Diagnostic Reagent Tech.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Diagnostic Reagent Tech.” (first 1982, latest 1984), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 69 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 |
|---|---|---|---|
| DGO | Ige, Peroxidase, Antigen, Antiserum, Control | 5 | 5 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | 2 |
| DAA | Igg, Peroxidase, Antigen, Antiserum, Control | 1 | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 | 1 |
Plus 1 more product codes.
Review panels
- Pathology (6)
- Immunology (3)
Most recent Diagnostic Reagent Tech. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843302 | NEW ALLERG. COATED MICROFILTER WELL STRI | DHB | 1984-10-04 | 42 |
| K832345 | POLYSTYRENE MICROTITER WELL IMMUNOSOR | DGC | 1983-11-25 | 130 |
| K832344 | POLYSTYRENE MICROTITER PLATE IMMUNO- | DHB | 1983-11-21 | 131 |
| K831984 | POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE | DGO | 1983-11-21 | 154 |
| K831496 | ALLERGEN IMMUNOSORBENTS IP SPECIFIC E | — | 1983-08-08 | 90 |
| K831774 | LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- | DGO | 1983-07-18 | 46 |
| K830005 | IP SPECIFIC G | DAA | 1983-06-02 | 150 |
| K830653 | POLYSTYRENE MICROTITER PLATE IMMUNOSORB | DGO | 1983-04-08 | 38 |
| K830495 | POLYSTYRENE MICROTITER PLATE IMMUNOSOR | DGO | 1983-04-05 | 48 |
| K821094 | IP SPECIFIC E | DGO | 1982-05-07 | 18 |
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Reagent Tech..
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.
- Diagnostic Products Corp. (324 510(k)s)
- Diagnostic Systems Laboratories, Inc. (94 510(k)s)
- Diagnostic Chemicals, Ltd. (Usa) (77 510(k)s)
- Diagnostic Chemicals , Ltd. (66 510(k)s)
- Diagnostic Reagents, Inc. (66 510(k)s)
- Diagnostic Hybrids, Inc. (36 510(k)s)
- Diagnostic Technology, Inc. (28 510(k)s)
- Diagnostic Solutions, Inc. (26 510(k)s)
- Diagnostic Ultrasound Corp. (16 510(k)s)
- Diagnostic Systems (14 510(k)s)
- Diagnostic Specialties (8 510(k)s)
- Diagnostic Medical Instruments (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diagnostic Reagent Tech.?
FDA lists 10 510(k) clearances under the applicant name “Diagnostic Reagent Tech.” (first 1982, latest 1984), across 5 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 Diagnostic Reagent Tech.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Reagent Tech. is 69 days.
Which FDA product codes appear under Diagnostic Reagent Tech.?
The most frequent FDA product codes under this applicant name are DGO (Ige, Peroxidase, Antigen, Antiserum, Control, 5); DHB (System, Test, Radioallergosorbent (Rast) Immunological, 2); DAA (Igg, Peroxidase, Antigen, Antiserum, Control, 1).
Next steps
- See all 10 Diagnostic Reagent Tech. clearances with predicates and recalls
- Run predicate analysis for product code DGO, Diagnostic Reagent Tech.'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.