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510(k) K791897

BACTO-HATTS by Difco Laboratories, Inc. — Product Code GMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
September 25, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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