The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Albumin Cp, Abx Pentra Micro-albumin Cp, Abx Pentra Total Protein Cp, Abx Pentra Multical.
| Device ID | K060434 |
| 510k Number | K060434 |
| Device Name: | ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Contact | Tim Lawton |
| Correspondent | Tim Lawton HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Product Code | CIX |
| Subsequent Product Code | CEK |
| Subsequent Product Code | DCF |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-21 |
| Decision Date | 2007-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230005187 | K060434 | 000 |
| 03610230005224 | K060434 | 000 |