K912534 is an FDA 510(k) clearance for the IMX HCG. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 1, 1991, 24 days after receiving the submission on June 7, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K912534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1991 |
| Decision Date | July 01, 1991 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JHI — Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |