510(k) K940048

STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION by Solarcare Technologies Corp,Inc. — Product Code DLJ

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