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510(k) K021394

DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM by Diamedix Corp. — Product Code DHR

K021394 is an FDA 510(k) premarket notification submitted by Diamedix Corp. for the device "DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 9, 2002. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Diamedix Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2002
Date Received
May 2, 2002
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 Diamedix Corp.

  • K093101 — MAGO 4S (January 21, 2011)
  • K013956 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN (January 8, 2002)
  • K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM (December 21, 2001)
  • K012450 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM (October 26, 2001)
  • K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM (October 26, 2001)
  • K012795 — DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM (September 28, 2001)
  • K012797 — DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM (September 28, 2001)
  • K012053 — DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM (August 20, 2001)
  • K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (November 28, 2000)
  • K001875 — DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM (August 21, 2000)

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)

FDA data resources