K083716 is an FDA 510(k) clearance for the FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC). This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on June 8, 2009, 175 days after receiving the submission on December 15, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K083716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2008 |
| Decision Date | June 08, 2009 |
| Days to Decision | 175 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 |