510(k) K955905

STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY by Solarcare Technologies Corp,Inc. — Product Code CEK

K955905 is an FDA 510(k) premarket notification submitted by Solarcare Technologies Corp,Inc. for the device "STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY". The FDA issued a decision of Substantially Equivalent on May 30, 1996. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Solarcare Technologies Corp,Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1996
Date Received
December 29, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biuret (Colorimetric), Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type