The following data is part of a premarket notification filed by Biological Corp. Of America with the FDA for Hematology Control.
| Device ID | K760162 |
| 510k Number | K760162 |
| Device Name: | HEMATOLOGY CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | BIOLOGICAL CORP. OF AMERICA 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 | 1976-07-06 |
| Decision Date | 1976-08-04 |