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510(k) K990431

AIA-PACK CA 125 by Tosoh Medics, Inc. — Product Code LTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1999
Date Received
February 11, 1999
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 Tosoh Medics, Inc.

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  • K023894 — ST AIA-PACK AFP ENZYME IMMUNOASSAY (December 17, 2002)
  • K023091 — ST AIA-PACK TESTOSTERONE ASSAY (December 17, 2002)
  • K023891 — ST AIA-PACK CA 125 ENZYME IMMUNOASSAY (December 6, 2002)
  • K020489 — G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (May 14, 2002)
  • K012820 — AIA-PACK CTNI 2ND-GEN ASSAY (December 14, 2001)
  • K011434 — G7 AUTOMATED HPLC ANALYZER (September 18, 2001)
  • K010796 — AIA-PACK BRCA, ST AIA PACK BRCA (August 16, 2001)
  • K992365 — AIA-PACK FOLATE ASSAY (August 10, 1999)
  • K991252 — AIA-PACK FT3 ASSAY (May 11, 1999)

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  • 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)