The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Cbc-5d Plus Retics Hematology Control, Models: 5dr03, 5dr04.
| Device ID | K072096 |
| 510k Number | K072096 |
| Device Name: | CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Nancy C Ring |
| Correspondent | Nancy C Ring 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 | 2007-07-31 |
| Decision Date | 2007-08-20 |
| Summary: | summary |