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510(k) K924036

ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST by J.S. Medical Assoc. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1992
Date Received
August 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

Other clearances by J.S. Medical Assoc.

  • K932752 — VISI-SPOT (November 5, 1993)
  • K932688 — EYE SPOT IM TEST (September 8, 1993)
  • K932180 — EYE SPOT CRP TEST (August 23, 1993)
  • K932551 — ACCUTEX IM LATEX TEST (August 9, 1993)
  • K926112 — ACCUTEX BETA-HCG TEST (July 28, 1993)
  • K924332 — ACCUTEX CRP LATEX TEST (December 7, 1992)
  • K924247 — ACCUTEX ASO LATEX TEST (December 7, 1992)
  • K924248 — ACCUTEX SLE LATEX TEST (November 2, 1992)
  • K924037 — ACCUTEX IM RBC TEST (November 2, 1992)
  • K912717 — J&S UIBC REAGENTS (September 25, 1991)

Other clearances for product code DHR

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  • K182747 — EliA RF IgM Immunoassay (December 18, 2018)
  • K162263 — Optilite Rheumatoid Factor Kit (May 3, 2017)
  • K160070 — Rheumatoid Factor (RF) Kit for use on SPAPLUS (December 7, 2016)
  • K143736 — ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA (September 23, 2015)
  • K102673 — RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (September 30, 2011)
  • K100499 — ORGENTEC RHEUMATOID FACTOR EIA (October 27, 2010)
  • K083080 — IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM (October 29, 2009)
  • K071247 — N LATEX RF KIT (August 8, 2007)