K821399 is an FDA 510(k) clearance for the MACRO-VUE CARD TEST, NETILMICIN. This device is classified as a Radioimmunoassay, Netilmicin (i-125) (Class II - Special Controls, product code LCE).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on May 28, 1982, 17 days after receiving the submission on May 11, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K821399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1982 |
| Decision Date | May 28, 1982 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCE — Radioimmunoassay, Netilmicin (i-125) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |