510(k) K941765
K941765 is an FDA 510(k) premarket notification submitted by Tcpi, Inc. for the device "HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE". The FDA issued a decision of Substantially Equivalent on October 20, 1994. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Tcpi, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1994
- Date Received
- March 25, 1994
- 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