Alta Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Alta Diagnostics, Inc.” (first 1979, latest 1980), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 | 1 |
| JGJ | Photometric Method, Magnesium | 1 | 1 |
| KHM | Nephelometric, Amylase | 1 | 1 |
| KJR | Erythrosin B | 1 | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Pathology (1)
Most recent Alta Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800327 | MAGNESIUM REAGENT | JGJ | 1980-03-25 | 42 |
| K792545 | URIC ACID KIT | KNK | 1980-01-29 | 50 |
| K792546 | FETAL CHECK | KJR | 1979-12-18 | 8 |
| K790797 | AMYLASE REAGENT SET | KHM | 1979-07-17 | 84 |
| K790796 | LIPASE REAGENT SET | CET | 1979-07-17 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Alta 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.
- Alta Medical Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alta Diagnostics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Alta Diagnostics, Inc.” (first 1979, latest 1980), across 5 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 Alta Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alta Diagnostics, Inc. is 50 days.
Which FDA product codes appear under Alta Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CET (Olive Oil Emulsion (Turbidimetric), Lipase, 1); JGJ (Photometric Method, Magnesium, 1); KHM (Nephelometric, Amylase, 1).
Next steps
- See all 5 Alta Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CET, Alta 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.