Ind Diagnostic, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Ind Diagnostic, Inc.” (first 2003, latest 2012), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 96 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 | 1 | 551 |
| 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 1 | 1 |
| KHE | Reagent, Occult Blood | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
| NGJ | Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Clinical Toxicology (2)
- Hematology (1)
Most recent Ind Diagnostic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103037 | IND URINARY TRACT INFECTION (UTI) TEST STRIPS | NGJ | 2012-04-17 | 551 |
| K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | KHE | 2010-07-19 | 194 |
| K063390 | URINE CHEMISTRY ANALYZER UR-50 | JIL | 2007-03-01 | 112 |
| K060810 | ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC | DKZ | 2006-08-07 | 136 |
| K052694 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. | JHI | 2005-12-16 | 79 |
| K052662 | ONE STEP FSH MENOPAUSAL TEST | CGJ | 2005-11-30 | 64 |
| K050741 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT | JHI | 2005-05-16 | 56 |
| K023638 | CASSETTE/URINE HCG | LCX | 2003-01-03 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Ind 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ind Diagnostic, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Ind Diagnostic, Inc.” (first 2003, latest 2012), across 7 product codes in 3 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 Ind Diagnostic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ind Diagnostic, Inc. is 96 days.
Which FDA product codes appear under Ind Diagnostic, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 2); CGJ (Radioimmunoassay, Follicle-Stimulating Hormone, 1); DKZ (Enzyme Immunoassay, Amphetamine, 1).
Next steps
- See all 8 Ind Diagnostic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Ind 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.