510(k) K792574

MOPSO BUFFER by Electrophoresis Corp. of America — Product Code JCC

K792574 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. of America for the device "MOPSO BUFFER". The FDA issued a decision of Substantially Equivalent on January 21, 1980. The device falls under product code JCC (Ph Buffer), a Class I device regulated under 21 CFR 864.4010. Electrophoresis Corp. of America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1980
Date Received
December 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Buffer
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type