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510(k) K892818

REP(TM) LD-2 STAT KIT, CAT. NO. 3078 by Helena Laboratories — Product Code CFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1989
Date Received
April 17, 1989
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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