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510(k) K912085

ACLAIMS-IS by W-Technology — Product Code LNJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1991
Date Received
May 13, 1991
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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