510(k) K934516
K934516 is an FDA 510(k) premarket notification submitted by Ortho Pharmaceutical Corp. for the device "ADVANCE PREGNANCY TEST MODIFICATION". The FDA issued a decision of Substantially Equivalent on February 24, 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. Ortho Pharmaceutical Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1994
- Date Received
- September 17, 1993
- 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