The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for R&d Cbc-3d + Crp Hematology Control.
| Device ID | K061511 |
| 510k Number | K061511 |
| Device Name: | R&D CBC-3D + CRP HEMATOLOGY CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Ralph E Hogancamp |
| Correspondent | Ralph E Hogancamp R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-01 |
| Decision Date | 2006-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274020395 | K061511 | 000 |
| 00817274020388 | K061511 | 000 |
| 00817274020371 | K061511 | 000 |
| 00817274020319 | K061511 | 000 |
| 00817274020302 | K061511 | 000 |
| 00817274020296 | K061511 | 000 |
| 00817274020289 | K061511 | 000 |
| 00817274020272 | K061511 | 000 |