510(k) K000844
K000844 is an FDA 510(k) premarket notification submitted by Mizuho USA, Inc. for the device "ABSOLUTE HCG PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on Jun 16, 2000. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Mizuho USA, Inc. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 16, 2000
- Date Received
- Mar 15, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Test, Human Chorionic Gonadotropin
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type
- 510(k)