510(k) K200913 · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Clearblue® Early Digital Pregnancy Test
| Applicant | Spd Swiss Precision Diagnostics GmbH, Geneva, CH |
| Decision | Substantially Equivalent, Aug 13, 2021 |
| Received | Apr 6, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200913
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2023 | Family Dollar Stores, Llc. CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 Open, Classified |
LCX | None listed |
| Aug 17, 2022 | Family Dollar Stores, Llc. CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260 Open, Classified |
LCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.