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510(k) K060709

MULTIGENT GENTAMICIN by Seradyn, Inc. — Product Code LCD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2006
Date Received
March 16, 2006
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

Other clearances by Seradyn, Inc.

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  • K062204 — ARCHITECT CORTISOL ASSAY (September 22, 2006)
  • K060998 — QMS TOBRAMYCIN (July 21, 2006)
  • K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (December 23, 2005)
  • K051211 — QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (November 18, 2005)
  • K052815 — QMS AMIKACIN REAGENTS (November 1, 2005)
  • K050419 — QMS VANCOMYCIN (April 1, 2005)
  • K042307 — ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) (November 3, 2004)
  • K033674 — MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS (February 9, 2004)

Other clearances for product code LCD

  • K243500 — ARCHITECT iGentamicin (July 9, 2025)
  • K102699 — ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS (April 1, 2011)
  • K042479 — VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS (January 6, 2005)
  • K020704 — ROCHE ONLINE GENTAMICIN (July 12, 2002)
  • K012978 — RANDOX GENTAMICIN (September 18, 2001)
  • K012311 — IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) (August 20, 2001)
  • 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)
  • K953020 — ACS GENTAMICIN (August 2, 1995)