The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Blood, Hematology Reference Control.
| Device ID | K781969 |
| 510k Number | K781969 |
| Device Name: | BLOOD, HEMATOLOGY REFERENCE CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-24 |
| Decision Date | 1979-01-03 |