Olympus Life & Material Science Europa GmbH (Irish
Irving, TX, US
Olympus Life & Material Science Europa GmbH (Irish appears in FDA device records in Irving, TX. FDA records list 3 510(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
- 3
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 3 510(k) clearances for Olympus Life & Material Science Europa GmbH (Irish in 2007.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K070708 | OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 | CEC | Substantially Equivalent | |
| K070453 | OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL | GHH | Substantially Equivalent | |
| K070835 | OLYMPUS CK-MB REAGENT | JHY | 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