K060434 is an FDA 510(k) clearance for the ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL. This device is classified as a Bromcresol Green Dye-binding, Albumin (Class II - Special Controls, product code CIX).
Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on June 5, 2007, 469 days after receiving the submission on February 21, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1035.
| 510(k) Number | K060434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2006 |
| Decision Date | June 05, 2007 |
| Days to Decision | 469 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIX — Bromcresol Green Dye-binding, Albumin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1035 |