510(k) K772112

NON-FERMENTER SYSTEM by Corning Medical & Scientific — Product Code JSW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1977
Date Received
November 7, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Glucose Nonfermenter
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type