K891375 is an FDA 510(k) clearance for the IQ ALBUMIN. This device is classified as a Bromcresol Green Dye-binding, Albumin (Class II - Special Controls, product code CIX).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 5, 1989, 57 days after receiving the submission on March 9, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1035.
| 510(k) Number | K891375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1989 |
| Decision Date | May 05, 1989 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIX — Bromcresol Green Dye-binding, Albumin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1035 |