The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for R&d 5d Retic Hematology Control.
| Device ID | K130962 |
| 510k Number | K130962 |
| Device Name: | R&D 5D RETIC HEMATOLOGY CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Ambreen Athar |
| Correspondent | Ambreen Athar 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 | 2013-04-08 |
| Decision Date | 2013-07-24 |
| Summary: | summary |