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510(k) K935376

AXSYM GENTAMICIN by Abbott Mfg., Inc. — Product Code LCD

K935376 is an FDA 510(k) premarket notification submitted by Abbott Mfg., Inc. for the device "AXSYM GENTAMICIN". The FDA issued a decision of Substantially Equivalent on June 21, 1994. The device falls under product code LCD (Enzyme Immunoassay, Gentamicin), a Class II device regulated under 21 CFR 862.3450. Abbott Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1994
Date Received
November 8, 1993
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 Abbott Mfg., Inc.

  • K981457 — ALBP (May 27, 1998)
  • K981232 — CA (May 18, 1998)
  • K981231 — CO2 (May 12, 1998)
  • K965230 — ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP (July 3, 1997)
  • K971293 — LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE (June 27, 1997)
  • K953656 — ABBOTT IMX PROLACTIN(MODIFICATION) (October 3, 1995)
  • K953657 — ABBOTT AXSYM PROLACTIN(MODIFICATION) (September 25, 1995)
  • K944669 — FLEXIFLO QUANTUM ENTERAL PUMP (July 24, 1995)
  • K943691 — IMX FOLATE (March 23, 1995)
  • K943733 — FLEXIFLO SIX ENTERAL NUTRITION PUMP (December 12, 1994)

Other clearances for product code LCD

  • K243500 — ARCHITECT iGentamicin (July 9, 2025)
  • K102699 — ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS (April 1, 2011)
  • K060709 — MULTIGENT GENTAMICIN (June 15, 2006)
  • 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)

FDA data resources