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510(k) K832314

CARDIZYME PLUS LD #65094/93 by Em Industries, Inc. — Product Code CFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1983
Date Received
July 14, 1983
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

Other clearances by Em Industries, Inc.

  • K823756 — ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 (January 12, 1983)

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