K060325 is an FDA 510(k) clearance for the ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P. This device is classified as a Diazo Colorimetry, Bilirubin (Class II - Special Controls, product code CIG).
Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on August 16, 2006, 188 days after receiving the submission on February 9, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K060325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2006 |
| Decision Date | August 16, 2006 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |