K844426 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 Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 7, 1985, 53 days after receiving the submission on November 15, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1035.
| 510(k) Number | K844426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1984 |
| Decision Date | January 07, 1985 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CJW — Bromcresol Purple Dye-binding, Albumin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1035 |