Diagnostic Technology, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Diagnostic Technology, Inc.” (first 1979, latest 1991), across 19 product codes in 5 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 5 | 5 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 3 | 3 |
| JPK | Mixture, Hematology Quality Control | 3 | 3 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 2 | 2 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | 1 |
| HIS | Condom | 1 | 1 |
| JCM | Control, Hemoglobin, Abnormal | 1 | 1 |
| KRX | Calibrator For Cell Indices | 1 | 1 |
Plus 9 more product codes.
Review panels
- Hematology (11)
- Microbiology (9)
- Clinical Chemistry (3)
- Immunology (3)
- Obstetrics and Gynecology (1)
Most recent Diagnostic Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896378 | LYME-CHECK(TM) TEST KIT | LSR | 1991-11-05 | 729 |
| K903612 | EBV/EA-CHECK TM TEST KIT | LSE | 1990-10-16 | 68 |
| K891542 | EBNA-CHECK(TM) TEST KIT | LLM | 1989-06-20 | 95 |
| K890819 | HSV-CHECK(TM) TEST KIT | HIS | 1989-06-20 | 123 |
| K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT | LJN | 1989-06-20 | 132 |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | GNP | 1987-06-25 | 79 |
| K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | LJP | 1987-04-29 | 190 |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | GNP | 1986-11-28 | 86 |
| K860586 | PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS | GKL | 1986-05-07 | 77 |
| K860166 | PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 | GKL | 1986-04-04 | 77 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Technology, 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.
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 Solutions, Inc. (26 510(k)s)
- Diagnostic Ultrasound Corp. (16 510(k)s)
- Diagnostic Systems (14 510(k)s)
- Diagnostic Reagent Tech. (10 510(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 Technology, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Diagnostic Technology, Inc.” (first 1979, latest 1991), across 19 product codes in 5 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 Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Technology, Inc. is 70 days.
Which FDA product codes appear under Diagnostic Technology, Inc.?
The most frequent FDA product codes under this applicant name are GKL (Counter, Cell, Automated (Particle Counter), 5); JHJ (Agglutination Method, Human Chorionic Gonadotropin, 3); JPK (Mixture, Hematology Quality Control, 3).
Next steps
- See all 28 Diagnostic Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKL, Diagnostic Technology, 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.