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510(k) K964185

IMX CA 125 by Abbott Diagnostics — Product Code LTK

K964185 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics for the device "IMX CA 125". The FDA issued a decision of Substantially Equivalent on November 4, 1997. The device falls under product code LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)), a Class II device regulated under 21 CFR 866.6010. Abbott Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1997
Date Received
October 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances by Abbott Diagnostics

  • K972182 — ABBOTT STREP A CONTROLS (August 13, 1997)
  • K961439 — ABBOTT CELL-DYN 4000 SYSTEM (October 18, 1996)
  • K890491 — CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER (April 18, 1989)
  • K881242 — CELL-DYN RAPID-LYSE AND HEMOGLOBLIN (April 21, 1988)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (September 9, 1987)
  • K873408 — MODEL 690 SPECTROPHOTOMETER (September 8, 1987)
  • K872761 — CELL-DYN 610 HEMATOLOGY ANALYZER (August 6, 1987)
  • K870233 — CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER (March 17, 1987)

Other clearances for product code LTK

  • K240479 — Access OV Monitor (May 10, 2024)
  • K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (September 8, 2023)
  • K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent Pack (December 12, 2022)
  • K200199 — ADVIA Centaur CA 125II (April 6, 2020)
  • K143534 — Elecsys CA-125 II assay (August 6, 2015)
  • K142895 — LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULS (May 21, 2015)
  • K100321 — DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 C (April 12, 2011)
  • K080469 — VIDAS CA 15-3 ASSAY (June 22, 2009)
  • K080561 — VIDAS CA 125 II ASSAY (April 10, 2009)
  • K072794 — IMMULITE 2500 OM-MA, MODEL L5KOP (November 5, 2007)

FDA data resources