K981814 is an FDA 510(k) clearance for the ALBP. This device is classified as a Bromcresol Purple Dye-binding, Albumin (Class II - Special Controls, product code CJW).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on July 22, 1998, 61 days after receiving the submission on May 22, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1035.
| 510(k) Number | K981814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1998 |
| Decision Date | July 22, 1998 |
| Days to Decision | 61 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 |