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510(k) K843560

BACTO STAPHYLOCOCCUS LATEX TEST by Difco Laboratories, Inc. — Product Code JWX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1984
Date Received
September 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Staphylococcus Aureus
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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