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510(k) K861750

CK/LD BUFFER (CAT. NO. 5808) by Helena Laboratories — Product Code CFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1986
Date Received
May 6, 1986
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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