The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Erytrol.
| Device ID | K050721 |
| 510k Number | K050721 |
| Device Name: | ABX ERYTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Contact | Tim Lawton |
| Correspondent | Tim Lawton HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-21 |
| Decision Date | 2005-06-01 |
| Summary: | summary |