510(k) K862195
K862195 is an FDA 510(k) premarket notification submitted by New Horizons Diagnostics Co. for the device "RAPID BACTERIURIA SCREEN (RBS)". The FDA issued a decision of Substantially Equivalent on Jun 30, 1986. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. New Horizons Diagnostics Co. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 30, 1986
- Date Received
- Jun 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Screening, Urine
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type