The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Cbc-4k Hematology Control.
| Device ID | K003874 |
| 510k Number | K003874 |
| Device Name: | CBC-4K HEMATOLOGY CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Kenneth Edds |
| Correspondent | Kenneth Edds 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 | 2000-12-15 |
| Decision Date | 2001-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274020357 | K003874 | 000 |
| 00817274020340 | K003874 | 000 |
| 00817274020333 | K003874 | 000 |
| 00817274020326 | K003874 | 000 |
| 00847661004929 | K003874 | 000 |
| 00847661004912 | K003874 | 000 |
| 00847661004905 | K003874 | 000 |
| 00847661004899 | K003874 | 000 |
| 00847661004882 | K003874 | 000 |