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510(k) K800493

BACTOGEN-H. INFLUENZAE TYPE B by Armkel, LLC — Product Code GRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1980
Date Received
March 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Types, Hemophilus Spp.
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

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Other clearances for product code GRO

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