K203272 is an FDA 510(k) clearance for the Alltest Pregnancy Rapid Combo Test Cassette. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 31, 2022, 451 days after receiving the submission on November 6, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K203272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2020 |
| Decision Date | January 31, 2022 |
| Days to Decision | 451 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHI - Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |