The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for 4c Abnormal Low-high (8 X 6 M1).
| Device ID | K760682 |
| 510k Number | K760682 |
| Device Name: | 4C ABNORMAL LOW-HIGH (8 X 6 M1) |
| 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 | 1976-09-20 |
| Decision Date | 1976-10-08 |