Intl. Diagnostic Technology: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Intl. Diagnostic Technology” (first 1976, latest 1985), across 25 product codes in 4 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| GLZ | Antigens, If, Toxoplasma Gondii | 2 | 2 |
| GOL | Antigen, Ha (Including Ha Control), Rubella | 2 | 2 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 2 | 2 |
| CZN | Iga, Fitc, Antigen, Antiserum, Control | 1 | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 | 1 |
| DAB | Haptoglobin, Fitc, Antigen, Antiserum, Control | 1 | 1 |
| DBI | Complement C4, Antigen, Antiserum, Control | 1 | 1 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
Plus 15 more product codes.
Review panels
- Immunology (19)
- Microbiology (6)
- Clinical Toxicology (3)
- Clinical Chemistry (1)
Most recent Intl. Diagnostic Technology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850591 | FIAX TOXO-M ANTIBODIES TEST KIT | GLZ | 1985-04-30 | 75 |
| K843570 | FIAX HAPTOGLOBIN TEST KIT | DAB | 1984-10-05 | 24 |
| K843621 | FIAX 420 DILUTOR | JQW | 1984-09-28 | 14 |
| K843356 | FIAX 100 FLUOROMETER | JZT | 1984-09-17 | 21 |
| K842749 | FIAX TOTAL IGE TEST KIT | DGP | 1984-08-28 | 46 |
| K842071 | FIAX TRANSFERRIN TEST KIT | DDI | 1984-07-11 | 49 |
| K841174 | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | GOL | 1984-06-07 | 80 |
| K840867 | ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN | DEI | 1984-05-11 | 74 |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | KTL | 1984-01-20 | 51 |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | KTL | 1984-01-04 | 48 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intl. Diagnostic Technology.
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.
- Intl. Immunoassay Laboratories, Inc. (27 510(k)s)
- Intl. Medical, Inc. (17 510(k)s)
- Intl. Remote Imaging Systems (14 510(k)s)
- Intl. Medical Devices , Ltd. (12 510(k)s)
- Intl. Playtex, Inc. (10 510(k)s)
- Intl. Business Machines (8 510(k)s)
- Intl. Bioclinical, Inc. (6 510(k)s)
- Intl. Diagnostic, Inc. (6 510(k)s)
- Intl. Medical Consultants (6 510(k)s)
- Intl. Medical Equipment Corp. (6 510(k)s)
- Intl. Ophthalmic Industries Corp. (6 510(k)s)
- Intl. Trade Management Co. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intl. Diagnostic Technology?
FDA lists 29 510(k) clearances under the applicant name “Intl. Diagnostic Technology” (first 1976, latest 1985), across 25 product codes in 4 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 Intl. Diagnostic Technology?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intl. Diagnostic Technology is 46 days.
Which FDA product codes appear under Intl. Diagnostic Technology?
The most frequent FDA product codes under this applicant name are DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 2); GLZ (Antigens, If, Toxoplasma Gondii, 2); GOL (Antigen, Ha (Including Ha Control), Rubella, 2).
Next steps
- See all 29 Intl. Diagnostic Technology clearances with predicates and recalls
- Run predicate analysis for product code DHN, Intl. Diagnostic Technology'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.