The following data is part of a premarket notification filed by Horiba Abx S.a.s. with the FDA for Abx Pentra Calcium As Cp, Abx Pentra Urine Control L/h, Abx Pentra Multical, Abx Pentra N Control, And Abx Pentra P Cont.
| Device ID | K123171 |
| 510k Number | K123171 |
| Device Name: | ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT |
| Classification | Azo Dye, Calcium |
| 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 | CJY |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-09 |
| Decision Date | 2013-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230005750 | K123171 | 000 |