510(k) K122907
K122907 is an FDA 510(k) premarket notification submitted by Polymed Therapeutics, Inc. for the device "FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER". The FDA issued a decision of Substantially Equivalent on March 14, 2013. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Polymed Therapeutics, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2013
- Date Received
- September 21, 2012
- 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