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510(k) K980833

IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 by Diagnostic Products Corp. — Product Code JMM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1998
Date Received
March 4, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Column Chromatography & Color Development, Hydroxyproline
Device Class
Class I
Regulation Number
862.1400
Review Panel
CH
Submission Type

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