510(k) K883206

LACTATE DEHYDROGENASE LDH by Electro-Nucleonics, Inc. — Product Code CFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1988
Date Received
July 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
Submission Type