Company ยท US
Mizuho USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2006. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 19, 2006 | K060825 | MULTI-USE ELECTRONIC PREGNANCY TEST Mizuho USA, Inc. | LCX |
| Apr 25, 2005 | K043231 | PROOF POSITIVE ELECTRONIC PREGNANCY TEST Mizuho USA, Inc. | LCX |
| Jun 16, 2000 | K000844 | ABSOLUTE HCG PREGNANCY TEST Mizuho USA, Inc. | DHA |
| Nov 7, 1996 | K964002 | NATURALE HCG PREGNANCY TES Mizuho USA, Inc. | LCX |
| Feb 10, 1995 | K943859 | QUICK CHECKER HCG PREGNANCY TEST Mizuho USA, Inc. | JHI |
| Jan 17, 1995 | K945568 | HCG MIDSTREAM PREGNANCY TEST Mizuho USA, Inc. | LCX |
| Sep 10, 1993 | K931997 | HCG MIDSTREAM PREGNANCY TEST Mizuho USA, Inc. | LCX |
Latest recalls
| 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 | K060825 |