Medical Diagnostic Technologies, Inc.: FDA clearances and approvals
Medical Diagnostic Technologies, Inc. has 57 FDA 510(k) clearances (first 1985, latest 2006), across 28 product codes in 5 review panels. Median 510(k) review time: 52 days.
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 |
|---|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | 10 | 10 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 5 | 5 |
| GGC | Control, Plasma, Abnormal | 4 | 4 |
| LSR | Reagent, Borrelia Serological Reagent | 4 | 4 |
| DIF | Drug Mixture Control Materials | 3 | 3 |
| GFO | Activated Partial Thromboplastin | 3 | 3 |
| GHR | Reagent, Platelet Aggregation | 2 | 2 |
| GIZ | Plasma, Control, Normal | 2 | 2 |
| GSA | Antisera, All Mycoplasma Spp. | 2 | 2 |
| JCO | Bothrops Atrox Reagent | 2 | 2 |
Plus 18 more product codes.
Review panels
- Hematology (32)
- Microbiology (13)
- Clinical Chemistry (8)
- Clinical Toxicology (3)
- Radiology (1)
Most recent Medical Diagnostic Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062229 | CTC WORKSTATION, MODEL 2200 | LLZ | 2006-09-11 | 40 |
| K972209 | SPECTROLYSE HEPARIN (ANTI-IIA) | KFF | 1997-08-12 | 62 |
| K963106 | CHROMOLIZE PAI-1 KIT | GGP | 1996-11-18 | 98 |
| K960871 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | JBQ | 1996-08-14 | 163 |
| K962489 | CHROMOLIZE TPA ASSAY KIT | GGP | 1996-07-31 | 35 |
| K960438 | TINTELIZE PAI-1 KIT | GGP | 1996-06-05 | 126 |
| K961724 | U-DOA CONTROLS | DIF | 1996-06-03 | 31 |
| K961370 | LA POSITIVE CONTROL PLASMA | GGC | 1996-05-24 | 45 |
| K955115 | VENOM TIEM REAGENT | JCO | 1996-04-03 | 146 |
| K955738 | BIOCLOT PROTEIN S | GGP | 1996-02-29 | 76 |
47 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Diagnostic Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Medical Diagnostic Technologies, Inc.'s product codes (a text match, not an official crosswalk):
- J7197 — Antithrombin iii (human), per i.u. (via JBQ)
- J7213 — Injection, coagulation factor ix (recombinant), ixinity, 1 i.u. (via GJT)
Frequently asked questions
How many FDA 510(k) clearances does Medical Diagnostic Technologies, Inc. have?
Medical Diagnostic Technologies, Inc. has 57 FDA 510(k) clearances (first 1985, latest 2006), across 28 product codes in 5 review panels.
How long does FDA take to clear Medical Diagnostic Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medical Diagnostic Technologies, Inc.'s cleared 510(k)s is 52 days.
What devices does Medical Diagnostic Technologies, Inc. make?
Its most frequent FDA product codes are GJT (Plasma, Coagulation Factor Deficient, 10); GGP (Test, Qualitative And Quantitative Factor Deficiency, 5); GGC (Control, Plasma, Abnormal, 4).
Has Medical Diagnostic Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medical Diagnostic Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 57 Medical Diagnostic Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GJT, Medical Diagnostic Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.