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510(k) K872078

QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL by Solomon Park Research Laboratories — Product Code DER

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1987
Date Received
May 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5580
Review Panel
IM
Submission Type

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