510(k) K913315

BIO-RAD TOTAL PROTEIN TEST KIT by Bio-Rad — Product Code CEF

K913315 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "BIO-RAD TOTAL PROTEIN TEST KIT". The FDA issued a decision of Substantially Equivalent on January 2, 1992. The device falls under product code CEF (Electrophoretic, Protein Fractionation), a Class I device regulated under 21 CFR 862.1630. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1992
Date Received
July 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic, Protein Fractionation
Device Class
Class I
Regulation Number
862.1630
Review Panel
CH
Submission Type