510(k) K112101
K112101 is an FDA 510(k) premarket notification submitted by Polymed Therapeutics, Inc. for the device "FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS". The FDA issued a decision of Substantially Equivalent on July 17, 2012. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), 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
- July 17, 2012
- Date Received
- July 22, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Visual, Pregnancy Hcg, Prescription Use
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type