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510(k) K852306

REPLACEMENT REAGENTS FOR SMAC II SYSTEMS by Methodist Hospital of Memphis — Product Code JJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1985
Date Received
May 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Device Class
Class I
Regulation Number
862.2150
Review Panel
CH
Submission Type

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