Cala Diagnostics: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Cala Diagnostics” (first 1985, latest 1994), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 55 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | 6 | 6 |
| DKC | Alcohol Control Materials | 2 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 2 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 1 | 1 |
| LAS | Drug Specific Control Materials | 1 | 1 |
Review panels
- Clinical Chemistry (8)
- Clinical Toxicology (3)
- Hematology (1)
Most recent Cala Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944247 | CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL | JJT | 1994-10-31 | 61 |
| K944246 | CARDIOCHEX CKMB MASS MEASUREMENT CONTROL | JJT | 1994-10-31 | 61 |
| K944243 | CARDIOCHEX | JJT | 1994-10-27 | 57 |
| K930874 | LD-1 CONTROL-LEVEL 1 & 2 | JJX | 1993-04-22 | 62 |
| K930875 | CKMB CONTROL - LEVEL 1,2,3 | JJT | 1993-04-13 | 53 |
| K930873 | CKMB ISOENZYME CONTROL-LEVEL 1,2.3 | JJT | 1993-04-13 | 53 |
| K926015 | CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 | JJX | 1992-12-28 | 28 |
| K915503 | FIBRINOGEN FDP CONTROL | DAP | 1992-01-30 | 52 |
| K912827 | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 | DKC | 1991-08-12 | 47 |
| K912826 | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 | DKC | 1991-07-26 | 30 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cala Diagnostics.
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.
- Cala Health, Inc. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cala Diagnostics?
FDA lists 12 510(k) clearances under the applicant name “Cala Diagnostics” (first 1985, latest 1994), across 5 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 Cala Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cala Diagnostics is 55 days.
Which FDA product codes appear under Cala Diagnostics?
The most frequent FDA product codes under this applicant name are JJT (Enzyme Controls (Assayed And Unassayed), 6); DKC (Alcohol Control Materials, 2); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 2).
Next steps
- See all 12 Cala Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JJT, Cala Diagnostics'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.