The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Beckman Coulter Ferritin Reagent, Model: Osr61203.
| Device ID | K092505 |
| 510k Number | K092505 |
| Device Name: | BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | BECKMAN COULTER, INC. LISMEEHAN, O'CALLAGHAN'S MILLS Co. Clare, IE |
| Contact | Catriona Neilan |
| Correspondent | Catriona Neilan BECKMAN COULTER, INC. LISMEEHAN, O'CALLAGHAN'S MILLS Co. Clare, IE |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-14 |
| Decision Date | 2009-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590011901 | K092505 | 000 |