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510(k) K921455

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1992
Date Received
March 27, 1992
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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