510(k) K821303

HI-PHORE HIGH RESOLUTION ELECTROPHORES by Gelman Sciences, Inc. — Product Code JJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1982
Date Received
May 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrophoresis, For Clinical Use
Device Class
Class I
Regulation Number
862.2485
Review Panel
CH
Submission Type