510(k) K964002
K964002 is an FDA 510(k) premarket notification submitted by Mizuho USA, Inc. for the device "NATURALE HCG PREGNANCY TES". The FDA issued a decision of Substantially Equivalent on Nov 7, 1996. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), 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
- Nov 7, 1996
- Date Received
- Oct 7, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Kit, Test, Pregnancy, Hcg, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type
- 510(k)