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510(k) K130332

VITROS CHEMISTRY PRODUCTS TRIG SLIDES by Ortho-Clinical Diagnostics, Inc. — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2013
Date Received
February 11, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

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