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510(k) K994338

AUTOSTAT II RHEUMATOID FACTOR IGM ELISA by Cogent Diagnotics , Ltd. — Product Code DHR

K994338 is an FDA 510(k) premarket notification submitted by Cogent Diagnotics , Ltd. for the device "AUTOSTAT II RHEUMATOID FACTOR IGM ELISA". The FDA issued a decision of Substantially Equivalent on February 3, 2000. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Cogent Diagnotics , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2000
Date Received
December 23, 1999
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 Cogent Diagnotics , Ltd.

  • K003054 — AUTOSTAT II ENA-6 PROFILE ELISA (October 13, 2000)
  • K003057 — AUTOSTAT II ENA-4 PROFILE ELISA (October 13, 2000)
  • K002215 — AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA (September 28, 2000)
  • K993557 — AUTOSTAT II RHEUMATOID FACTOR IGA ELISA (March 3, 2000)
  • K993085 — AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA (February 1, 2000)
  • K993304 — AUTOSTAT II RHEUMATOID FACTOR IGG ELISA (December 6, 1999)
  • K992449 — AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA (November 24, 1999)
  • K993087 — AUTOSTAT II ANTI-GLIADIN IGG ELISA (November 12, 1999)
  • K993086 — AUTOSTAT II ANTI-GLIADIN IGA ELISA (November 12, 1999)
  • K992440 — AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA (September 21, 1999)

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