The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for S-cal Hematology Calibrator.
| Device ID | K862122 |
| 510k Number | K862122 |
| Device Name: | S-CAL HEMATOLOGY CALIBRATOR |
| Classification | Calibrator For Platelet Counting |
| Applicant | COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
| Contact | Richardson-jones |
| Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
| Product Code | KRY |
| CFR Regulation Number | 864.8175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-03 |
| Decision Date | 1987-05-20 |