510(k) K060825 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
MULTI-USE ELECTRONIC PREGNANCY TEST
| Applicant | Mizuho USA, Inc., Poway CA, US |
| Decision | Substantially Equivalent, Jun 19, 2006 |
| Received | Mar 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2007 | Mizuho USA, Inc. Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138)
Note:
(1) Confirm Clearly Starter Kits: When sold in the U Terminated |
LCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.