The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Cbc-8k(tm) Hematology Control/multiple.
| Device ID | K913879 |
| 510k Number | K913879 |
| Device Name: | CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Karen Viskochil |
| Correspondent | Karen Viskochil 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 | 1991-08-29 |
| Decision Date | 1991-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273210200 | K913879 | 000 |