The following data is part of a premarket notification filed by Horiba Abx S.a.s. with the FDA for Abx Pentra Enzymatic Creatinine Cp, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P Control, And Abx Pentra Urin.
| Device ID | K110137 |
| 510k Number | K110137 |
| Device Name: | ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN |
| Classification | Enzymatic Method, Creatinine |
| Applicant | HORIBA ABX S.A.S. PARC EUROMEDECINE RUE DU CADUCEE-BP 7290 Montpellier Cedex 4, Herault, FR 34184 |
| Contact | Caroline Ferrer |
| Correspondent | Caroline Ferrer HORIBA ABX S.A.S. PARC EUROMEDECINE RUE DU CADUCEE-BP 7290 Montpellier Cedex 4, Herault, FR 34184 |
| Product Code | JFY |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-18 |
| Decision Date | 2011-08-10 |
| Summary: | summary |