The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Hba1c Wb, Calibrator, Control And Hemolysis Reagent.
| Device ID | K073309 |
| 510k Number | K073309 |
| Device Name: | ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier, FR 34184 |
| Contact | Olivier Ducamp |
| Correspondent | Olivier Ducamp HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier, FR 34184 |
| Product Code | LCP |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-23 |
| Decision Date | 2008-10-17 |
| Summary: | summary |