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510(k) K842669

TITAN GEL ISO DOT LDH KIT by Helena Laboratories — Product Code CFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1984
Date Received
July 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
Review Panel
CH
Submission Type

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