K901981 is an FDA 510(k) clearance for the ABBOTT MODIFIED FACT PLUS PREGNANCY TEST. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 2, 1990, 92 days after receiving the submission on May 2, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K901981 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1990 |
| Decision Date | August 02, 1990 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LCX — Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |