The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Hematology Calibrator S-cal.
| Device ID | K813375 |
| 510k Number | K813375 |
| Device Name: | HEMATOLOGY CALIBRATOR S-CAL |
| Classification | Calibrator For Red-cell And White-cell Counting |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSA |
| CFR Regulation Number | 864.8185 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-01 |
| Decision Date | 1982-02-04 |