K033041 is an FDA 510(k) clearance for the ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on November 21, 2003, 53 days after receiving the submission on September 29, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K033041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2003 |
| Decision Date | November 21, 2003 |
| Days to Decision | 53 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 |