The following data is part of a premarket notification filed by Metrix Teknika, Inc. with the FDA for Filter, Eyrpur Disposable Leukocite.
| Device ID | K781803 |
| 510k Number | K781803 |
| Device Name: | FILTER, EYRPUR DISPOSABLE LEUKOCITE |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | METRIX TEKNIKA, INC. MD |
| Product Code | GKT |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-23 |
| Decision Date | 1979-01-17 |