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510(k) K900107

LD-1 by Boehringer Mannheim Corp. — Product Code DET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1990
Date Received
January 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lactic Dehydrogenase, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5560
Review Panel
IM
Submission Type

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