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510(k) K895095

AKS II by Amoco Technology Co. — Product Code LNJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1990
Date Received
August 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chromosome, Automated
Device Class
Class II
Regulation Number
864.5260
Review Panel
PA
Submission Type

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