K880437 is an FDA 510(k) clearance for the VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM. This device is classified as a Diazo Colorimetry, Bilirubin (Class II - Special Controls, product code CIG).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 3, 1988, 183 days after receiving the submission on February 2, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K880437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1988 |
| Decision Date | August 03, 1988 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |