The following data is part of a premarket notification filed by American Scientific Products with the FDA for Blood Dilution Vial.
| Device ID | K844042 |
| 510k Number | K844042 |
| Device Name: | BLOOD DILUTION VIAL |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Mathew J Perry |
| Correspondent | Mathew J Perry AMERICAN SCIENTIFIC PRODUCTS 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-17 |
| Decision Date | 1984-10-23 |