K760045 is an FDA 510(k) clearance for the KIT, RADIOASSAY, SERUM IRON. This device is classified as a Radio-labeled Iron Method, Iron (non-heme) (Class I - General Controls, product code JJA).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on July 20, 1976, 35 days after receiving the submission on June 15, 1976.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1410.
| 510(k) Number | K760045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1976 |
| Decision Date | July 20, 1976 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJA — Radio-labeled Iron Method, Iron (non-heme) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1410 |