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510(k) K980770

HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 by Diagnostic Chemicals , Ltd. — Product Code LBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1998
Date Received
February 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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