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510(k) K972409

AG CHEMISTRY ANALYZER SYSTEM by Landmark Scientific, Inc. — Product Code JJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1997
Date Received
June 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class
Class I
Regulation Number
862.2140
Review Panel
CH
Submission Type

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