510(k) K925190
K925190 is an FDA 510(k) premarket notification submitted by New Horizons Diagnostics Co. for the device "PYLORISCREEN". The FDA issued a decision of Substantially Equivalent on Mar 23, 1993. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. New Horizons Diagnostics Co. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 23, 1993
- Date Received
- Oct 14, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Helicobacter Pylori
- Device Class
- Class I
- Regulation Number
- 866.3110
- Review Panel
- MI
- Submission Type