Mizuho USA, Inc.
San Diego, CA, US
Mizuho USA, Inc. appears in FDA device records in San Diego, CA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Mizuho USA, Inc. between 1993 and 2006. The busiest year on record is 1995, with 2. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1995 | 2 |
| 1996 | 1 |
| 2000 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K060825 | MULTI-USE ELECTRONIC PREGNANCY TEST | LCX | Substantially Equivalent | |
| K043231 | PROOF POSITIVE ELECTRONIC PREGNANCY TEST | LCX | Substantially Equivalent | |
| K000844 | ABSOLUTE HCG PREGNANCY TEST | DHA | Substantially Equivalent | |
| K964002 | NATURALE HCG PREGNANCY TES | LCX | Substantially Equivalent | |
| K943859 | QUICK CHECKER HCG PREGNANCY TEST | JHI | Substantially Equivalent | |
| K945568 | HCG MIDSTREAM PREGNANCY TEST | LCX | Substantially Equivalent | |
| K931997 | HCG MIDSTREAM PREGNANCY TEST | LCX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0469-2007 | 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.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick (2) Confirm Clearly Refills Kits: The refill consists of three disposable test sticks. | False positives-the firm has received a higher than expected rate of complaints regarding false-positive results. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain