Home / 510(k) Clearances / K972456

510(k) K972456

RHEUMACOL RHEUMATOID FACTOR TEST by Immunostics Inc., — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1997
Date Received
July 1, 1997
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 Immunostics Inc.,

  • K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer (September 22, 2023)
  • K182298 — hemochroma PLUS System (November 16, 2018)
  • K163465 — hemochroma PLUS System (September 8, 2017)
  • K163225 — AFIAS iFOB with AFIAS-50 (August 8, 2017)
  • K171484 — hema-screen SPECIFIC Gold (June 14, 2017)
  • K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (January 17, 2017)
  • K102664 — HEMA SCREEN ER (January 28, 2011)
  • K060463 — HEMA SCREEN SPECIFIC IFOBT (June 6, 2006)
  • K041728 — HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE (August 11, 2004)
  • K031490 — RUBELLACOL (July 16, 2003)

Other clearances for product code DHR

  • K192727 — K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) (May 20, 2020)
  • K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (April 17, 2019)
  • 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)