510(k) K940048
K940048 is an FDA 510(k) premarket notification submitted by Solarcare Technologies Corp,Inc. for the device "STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION". The FDA issued a decision of Substantially Equivalent on March 19, 1996. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Solarcare Technologies Corp,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1996
- Date Received
- January 5, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrators, Drug Specific
- Device Class
- Class II
- Regulation Number
- 862.3200
- Review Panel
- TX
- Submission Type