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 | K970331 |
| 510k Number | K970331 |
| 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 | Sue Gallo |
| Correspondent | Sue Gallo 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 | 1997-01-28 |
| Decision Date | 1997-04-16 |
| Summary: | summary |