K822241 is an FDA 510(k) clearance for the FOLATE/B12 DUO-BEAD RADIOASSAY. This device is classified as a Dye-indicator, Ph (urinary, Non-quantitative) (Class I - General Controls, product code CEN).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 26, 1982, 91 days after receiving the submission on July 27, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1550.
| 510(k) Number | K822241 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1982 |
| Decision Date | October 26, 1982 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEN — Dye-indicator, Ph (urinary, Non-quantitative) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1550 |