The following data is part of a premarket notification filed by Horiba Abx S.a.s. with the FDA for Abx Pentra Creatinine 120 Cp; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control.
| Device ID | K110530 |
| 510k Number | K110530 |
| Device Name: | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL |
| Classification | Alkaline Picrate, Colorimetry, 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 | CGX |
| 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 | 2011-02-24 |
| Decision Date | 2012-04-30 |
| Summary: | summary |