Iso-Data, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Iso-Data, Inc.” (first 1978, latest 1987), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| JJJ | Counter (Beta, Gamma) For Clinical Use | 3 | 3 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 2 | 2 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Iso-Data, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872430 | ISO-DATA 500 SERIES GAMMA COUNTER | JJJ | 1987-08-21 | 60 |
| K872429 | ISO-DATA 100 SERIES GAMMA COUNTER | JJJ | 1987-08-21 | 60 |
| K843434 | ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC. | JQC | 1984-10-05 | 31 |
| K843365 | ISO-DATA IMMUNOASSAY NETWORK SYSTEM | JQP | 1984-09-27 | 30 |
| K810631 | DPM CALCULATOR | JQP | 1981-03-27 | 17 |
| K780813 | IDI GDR DATA REDUCTION SYSTEM | — | 1978-06-28 | 44 |
| K780790 | IDI 200 GAMMA COUNTER | JJJ | 1978-06-22 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Iso-Data, 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 Iso-Data, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Iso-Data, Inc.” (first 1978, latest 1987), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Iso-Data, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Iso-Data, Inc. is 38 days.
Which FDA product codes appear under Iso-Data, Inc.?
The most frequent FDA product codes under this applicant name are JJJ (Counter (Beta, Gamma) For Clinical Use, 3); JQP (Calculator/Data Processing Module, For Clinical Use, 2); JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, 1).
Next steps
- See all 7 Iso-Data, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJJ, Iso-Data, 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.