510(k) K881925

VITEK YEAST BIOCHEMICAL CARD by Vitek Systems, Inc. — Product Code JXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1988
Date Received
May 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Yeast
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type