510(k) K062703
K062703 is an FDA 510(k) premarket notification submitted by Ai DE Diagnostic Co., Ltd. for the device "ONE STEP HCG PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on Jul 23, 2007. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 23, 2007
- Date Received
- Sep 11, 2006
- 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)