Irvine Diagnostic Services: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Irvine Diagnostic Services” (first 1984, latest 1984), across 1 product code in 1 review panel. Median 510(k) review time under this name: 12 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 |
|---|---|---|---|
| JSF | Culture Media, Single Biochemical Test | 10 | 10 |
Review panels
- Microbiology (10)
Most recent Irvine Diagnostic Services 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842871 | HIPPURATE TEST REAGENT | JSF | 1984-08-07 | 15 |
| K842869 | DECARBOXYLASE TEST REAGENT | JSF | 1984-08-07 | 15 |
| K842872 | INDOLE REAGENT | JSF | 1984-08-03 | 11 |
| K842870 | VOGES-PROSKAUER REAGENT A | JSF | 1984-08-03 | 11 |
| K842868 | HIPPURATE TEST DISKS | JSF | 1984-08-03 | 11 |
| K842867 | VOGES-PROSKAUER REAGENT B | JSF | 1984-08-03 | 11 |
| K842299 | ZINC DUST SUSPENSION | JSF | 1984-06-26 | 15 |
| K842298 | OXIDASE TEST STRIPS-OXIDASESURE | JSF | 1984-06-25 | 14 |
| K842300 | ONPG DISKS | JSF | 1984-06-22 | 11 |
| K842072 | L-ALANINE-4-NITROANILIDE | JSF | 1984-06-07 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Irvine Diagnostic Services.
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.
- Irvine Scientific Sales Co., Inc. (40 510(k)s)
- Irvine Scientific (16 510(k)s)
- Irvine Biomedical, Inc. (11 510(k)s)
- Irvine Biomedical,Inc.(Ibi) (1 510(k)s)
- Irvine Biomedical, A St. Jude Medical Company (1 510(k)s)
- Irvine Biomedical, Inc., A St. Jude Medical Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Irvine Diagnostic Services?
FDA lists 10 510(k) clearances under the applicant name “Irvine Diagnostic Services” (first 1984, latest 1984), across 1 product code 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 Irvine Diagnostic Services?
The median time from FDA receipt to decision across 510(k)s cleared under the name Irvine Diagnostic Services is 12 days.
Which FDA product codes appear under Irvine Diagnostic Services?
The most frequent FDA product codes under this applicant name are JSF (Culture Media, Single Biochemical Test, 10).
Next steps
- See all 10 Irvine Diagnostic Services clearances with predicates and recalls
- Run predicate analysis for product code JSF, Irvine Diagnostic Services'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.