K193132 is an FDA 510(k) clearance for the CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 11, 2019, 29 days after receiving the submission on November 12, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K193132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2019 |
| Decision Date | December 11, 2019 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCX - Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |