The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Cbc-cal Plus Hematology Calibrator.
| Device ID | K955925 |
| 510k Number | K955925 |
| Device Name: | CBC-CAL PLUS HEMATOLOGY CALIBRATOR |
| Classification | Calibrator For Cell Indices |
| 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 | KRX |
| Subsequent Product Code | KRY |
| Subsequent Product Code | KRZ |
| Subsequent Product Code | KSA |
| CFR Regulation Number | 864.8150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1996-02-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414600826 | K955925 | 000 |
| 06944904084152 | K955925 | 000 |