The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Creatinine 120 Cp, Total Protein 100 Cp, Multical, N And P Controls, And Urine Control L/h.
| Device ID | K072115 |
| 510k Number | K072115 |
| Device Name: | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Contact | Olivier Ducamp |
| Correspondent | Olivier Ducamp HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Product Code | CGX |
| Subsequent Product Code | CEK |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-01 |
| Decision Date | 2007-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230005125 | K072115 | 000 |