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510(k) K964009

IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS by Beckman Instruments, Inc. — Product Code DNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1997
Date Received
October 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemagglutination Inhibition, Gentamicin
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

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