Cala Diagnostics
Los Osos, CA, US
Cala Diagnostics appears in FDA device records in Los Osos, CA. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Cala Diagnostics between 1985 and 1994. The busiest year on record is 1993, with 3. The most recent is 1994, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1987 | 1 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 3 |
| 1994 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K944247 | CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL | JJT | Substantially Equivalent | |
| K944246 | CARDIOCHEX CKMB MASS MEASUREMENT CONTROL | JJT | Substantially Equivalent | |
| K944243 | CARDIOCHEX | JJT | Substantially Equivalent | |
| K930874 | LD-1 CONTROL-LEVEL 1 & 2 | JJX | Substantially Equivalent | |
| K930875 | CKMB CONTROL - LEVEL 1,2,3 | JJT | Substantially Equivalent | |
| K930873 | CKMB ISOENZYME CONTROL-LEVEL 1,2.3 | JJT | Substantially Equivalent | |
| K926015 | CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 | JJX | Substantially Equivalent | |
| K915503 | FIBRINOGEN FDP CONTROL | DAP | Substantially Equivalent | |
| K912827 | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 | DKC | Substantially Equivalent | |
| K912826 | WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 | DKC | Substantially Equivalent | |
| K864456 | CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 | LAS | Substantially Equivalent | |
| K850907 | CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ | JJT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain