The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Power Processor Sample Processing System With Generic Connections.
| Device ID | K110413 |
| 510k Number | K110413 |
| Device Name: | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS |
| Classification | Radioassay, Vitamin B12 |
| Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD Brea, CA 92822 |
| Contact | Marine Boyajian |
| Correspondent | Marine Boyajian BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD Brea, CA 92822 |
| Product Code | CDD |
| Subsequent Product Code | CGN |
| Subsequent Product Code | DBF |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JLW |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590604479 | K110413 | 000 |
| 15099590591960 | K110413 | 000 |
| 15099590583996 | K110413 | 000 |