K923322 is an FDA 510(k) clearance for the TRACE ALBUMIN-MR REAGENT. This device is classified as a Bromcresol Green Dye-binding, Albumin (Class II - Special Controls, product code CIX).
Submitted by Trace Scientific , Ltd. (Miami, US). The FDA issued a Cleared decision on September 11, 1992, 66 days after receiving the submission on July 7, 1992.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1035.
| 510(k) Number | K923322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1992 |
| Decision Date | September 11, 1992 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | CIX — Bromcresol Green Dye-binding, Albumin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1035 |