Home / 510(k) Clearances / K974370

510(k) K974370

RAPET RF by Stanbio Laboratory — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1998
Date Received
November 20, 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 Stanbio Laboratory

  • K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (June 10, 2009)
  • K081719 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (July 18, 2008)
  • K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR (June 30, 2005)
  • K050283 — CREATININE LIQUICOLOR (June 30, 2005)
  • K042169 — STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER (March 14, 2005)
  • K041155 — WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY (October 14, 2004)
  • K032936 — DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIB (March 12, 2004)
  • K032932 — DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR (March 10, 2004)
  • K032482 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (October 24, 2003)
  • K020378 — QUPID PLUS E.R. (June 21, 2002)

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)