510(k) K861460
K861460 is an FDA 510(k) premarket notification submitted by Widran Urological Group, Ltd. for the device "SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code LJK (Antisera, If, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Widran Urological Group, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1986
- Date Received
- April 18, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, If, Toxoplasma Gondii
- Device Class
- Class II
- Regulation Number
- 866.3780
- Review Panel
- MI
- Submission Type