510(k) K083716 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
| Applicant | Church & Dwight Co., Inc., Princeton NJ, US |
| Decision | Substantially Equivalent, Jun 8, 2009 |
| Received | Dec 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083716
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2023 | Church & Dwight Inc Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e Open, Classified |
LCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.