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510(k) K012978

RANDOX GENTAMICIN by Randox Laboratories, Ltd. — Product Code LCD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2001
Date Received
July 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Gentamicin
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

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  • K020704 — ROCHE ONLINE GENTAMICIN (July 12, 2002)
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  • K010984 — EMIT 2000 GENTAMICIN PLUS ASSAY (April 20, 2001)
  • K962819 — GENTAMICIN FLEX REAGENT CARTRIDGE (September 13, 1996)
  • K962519 — EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS (September 4, 1996)
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