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510(k) K931777

APO A-1 CHEMILUMINESCENCE ASSAY by Nichols Institute — Product Code MSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1993
Date Received
April 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apolipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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