Granite Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 47 510(k) clearances under the applicant name “Granite Diagnostics, Inc.” (first 1977, latest 1985), across 13 product codes in 2 review panels. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | 10 | 10 |
| JSI | Culture Media, Selective And Differential | 8 | 8 |
| JSF | Culture Media, Single Biochemical Test | 7 | 7 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 6 | 6 |
| JSH | Culture Media, Non-Selective And Differential | 5 | 5 |
| JSD | Culture Media, Selective Broth | 2 | 2 |
| JSE | Culture Media, Multiple Biochemical Test | 2 | 2 |
| JSG | Culture Media, Non-Selective And Non-Differential | 2 | 2 |
| HYI | Iodine, Grams | 1 | 1 |
| JSC | Culture Media, General Nutrient Broth | 1 | 1 |
Plus 3 more product codes.
Review panels
- Microbiology (46)
- Pathology (1)
Most recent Granite Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850970 | BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA | JSJ | 1985-03-29 | 21 |
| K850969 | INHIBITORY MOLD AGAR PLATE | JSJ | 1985-03-29 | 21 |
| K833254 | STREPTOCOCCUS ID TRIPLATE SYSTEM | JSI | 1983-10-28 | 38 |
| K832365 | TCBS AGAR | JSI | 1983-09-01 | 45 |
| K831349 | STREPTOCOCUS ID PLATE | JST | 1983-05-16 | 21 |
| K830252 | DIPCHEX DIP-SLIDE CULTURE SYS | JXA | 1983-03-07 | 41 |
| K830251 | CAMPY BLOOD AGAR PLATE | JSI | 1983-02-28 | 34 |
| K823248 | SCHAEDLER AGARS | JSJ | 1982-12-03 | 32 |
| K823139 | SMITH'S MEDIUM | JSJ | 1982-12-03 | 39 |
| K823122 | LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM | JSI | 1982-12-03 | 42 |
37 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Granite Diagnostics, 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.
- Granite Chemical Co., Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Granite Diagnostics, Inc.?
FDA lists 47 510(k) clearances under the applicant name “Granite Diagnostics, Inc.” (first 1977, latest 1985), across 13 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 Granite Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Granite Diagnostics, Inc. is 21 days.
Which FDA product codes appear under Granite Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JSJ (Culture Media, Selective And Non-Differential, 10); JSI (Culture Media, Selective And Differential, 8); JSF (Culture Media, Single Biochemical Test, 7).
Next steps
- See all 47 Granite Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSJ, Granite Diagnostics, 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.