510(k) K103574
K103574 is an FDA 510(k) premarket notification submitted by Lehnus & Associates Consulting for the device "PREGNANCY ONE STEP RAPID TEST". The FDA issued a decision of Substantially Equivalent on July 28, 2011. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Lehnus & Associates Consulting has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2011
- Date Received
- December 6, 2010
- 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