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510(k) K012311

IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) by Diagnostic Products Corp. — Product Code LCD

K012311 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)". The FDA issued a decision of Substantially Equivalent on August 20, 2001. The device falls under product code LCD (Enzyme Immunoassay, Gentamicin), a Class II device regulated under 21 CFR 862.3450. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2001
Date Received
July 23, 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

Other clearances by Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

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)
  • 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)

FDA data resources