The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for 3k-cal Hematology Calibrator/multiple.
| Device ID | K912357 |
| 510k Number | K912357 |
| Device Name: | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE |
| Classification | Calibrator For Cell Indices |
| 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 | KRX |
| CFR Regulation Number | 864.8150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-28 |
| Decision Date | 1991-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590639426 | K912357 | 000 |