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510(k) K011568

RANDOX LIPOPROTEIN by Randox Laboratories, Ltd. — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2001
Date Received
May 21, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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