510(k) K915785
K915785 is an FDA 510(k) premarket notification submitted by Solarcare Technologies Corp,Inc. for the device "STC DIAGNOSTICS BENZOYLECGONINE EIA". The FDA issued a decision of Substantially Equivalent on March 11, 1992. The device falls under product code JXO (Enzyme Immunoassay, Cocaine), a Class II device regulated under 21 CFR 862.3250. Solarcare Technologies Corp,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1992
- Date Received
- December 24, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cocaine
- Device Class
- Class II
- Regulation Number
- 862.3250
- Review Panel
- TX
- Submission Type