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510(k) K905861

ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH by E.I. Dupont DE Nemours & Co., Inc. — Product Code CFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1991
Date Received
December 31, 1990
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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