K102760 is an FDA 510(k) clearance for the ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by Atlas Medical (Amman, JO). The FDA issued a Cleared decision on August 3, 2011, 314 days after receiving the submission on September 23, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K102760 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2010 |
| Decision Date | August 03, 2011 |
| Days to Decision | 314 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 |