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510(k) K911429

VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED by Vitek Systems, Inc. — Product Code LQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
March 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram Negative Identification Panel
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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