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510(k) K855236

DIAGNOSTIC REAGENT TST-RPLA by Oxoid U.S.A., Inc. — Product Code GTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1986
Date Received
December 31, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Types, Staphylococcus Spp.
Device Class
Class I
Regulation Number
866.3700
Review Panel
MI
Submission Type

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Other clearances for product code GTN

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