Intl. Diagnostic, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Intl. Diagnostic, Inc.” (first 1978, latest 1984), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 3 | 3 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Immunology (2)
Most recent Intl. Diagnostic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841853 | PREG-BETA ONE HOUR TUBE TEST | JHJ | 1984-06-22 | 50 |
| K840833 | PREG BETA BLUS SLIDE | JHJ | 1984-05-30 | 96 |
| K834584 | NABI CRP-Q.S. TEST | DCN | 1984-02-27 | 60 |
| K840005 | NABI RF-Q.S. TEST | DHR | 1984-02-13 | 40 |
| K802343 | PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO | JHJ | 1980-10-10 | 14 |
| K780321 | PREGNANCY TEST KIT, OVER-THE-COUNTER | LCX | 1978-04-04 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Intl. 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.
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. Diagnostic Technology (29 510(k)s)
- 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. 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, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Intl. Diagnostic, Inc.” (first 1978, latest 1984), across 4 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 Intl. Diagnostic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intl. Diagnostic, Inc. is 45 days.
Which FDA product codes appear under Intl. Diagnostic, Inc.?
The most frequent FDA product codes under this applicant name are JHJ (Agglutination Method, Human Chorionic Gonadotropin, 3); DCN (System, Test, C-Reactive Protein, 1); DHR (System, Test, Rheumatoid Factor, 1).
Next steps
- See all 6 Intl. Diagnostic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHJ, Intl. 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, 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.