The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for R&d Systems Body Fluid-i Hematology Control.
| Device ID | K101578 |
| 510k Number | K101578 |
| Device Name: | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Nancy Ring |
| Correspondent | Nancy 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-07 |
| Decision Date | 2011-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815762020087 | K101578 | 000 |
| 00815762020070 | K101578 | 000 |