K810597 is an FDA 510(k) clearance for the MACRO-VUE CARD TEST. This device is classified as a Radioimmunoassay, Tobramycin (Class II - Special Controls, product code KLB).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on March 17, 1981, 11 days after receiving the submission on March 6, 1981.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K810597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1981 |
| Decision Date | March 17, 1981 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KLB — Radioimmunoassay, Tobramycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3900 |