The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Check Sample Unassayed Hematolog.
| Device ID | K843805 |
| 510k Number | K843805 |
| Device Name: | COULTER CHECK SAMPLE UNASSAYED HEMATOLOG |
| Classification | Mixture, Hematology Quality Control |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Contact | Richardson-jones |
| Correspondent | Richardson-jones 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 | 1984-09-27 |
| Decision Date | 1984-12-17 |