K811421 is an FDA 510(k) clearance for the HCG RADIOIMMUNOASSAY KIT (125I). This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on July 10, 1981, 51 days after receiving the submission on May 20, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K811421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 1981 |
| Decision Date | July 10, 1981 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JHI — Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |