K830997 is an FDA 510(k) clearance for the ARIA II I-HCG. 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 (Washington, US). The FDA issued a Cleared decision on June 2, 1983, 65 days after receiving the submission on March 29, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K830997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 1983 |
| Decision Date | June 02, 1983 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JHI — Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |