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510(k) K943978

WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS by Waters Chromatography Division — Product Code JJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1995
Date Received
August 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Micro, For Clinical Use
Device Class
Class I
Regulation Number
862.2170
Review Panel
CH
Submission Type

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