K193001 is an FDA 510(k) clearance for the Albumin BCP. This device is classified as a Bromcresol Purple Dye-binding, Albumin (Class II - Special Controls, product code CJW).
Submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on December 19, 2019, 52 days after receiving the submission on October 28, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1035.
| 510(k) Number | K193001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2019 |
| Decision Date | December 19, 2019 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJW - Bromcresol Purple Dye-binding, Albumin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1035 |