Home / 510(k) Clearances / K993843

510(k) K993843

MDI RF TEST by Micro Detect, Inc. — Product Code DHR

K993843 is an FDA 510(k) premarket notification submitted by Micro Detect, Inc. for the device "MDI RF TEST". The FDA issued a decision of Substantially Equivalent on January 11, 2000. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Micro Detect, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2000
Date Received
November 12, 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 Micro Detect, Inc.

  • K003794 — ELISA TEST, SEROLOGY (March 30, 2001)
  • K002358 — MDI GLIADIN A TEST (October 19, 2000)
  • K002359 — MDI GLIADIN G TEST (October 19, 2000)
  • K000934 — MDI SCL-70 TEST (April 7, 2000)
  • K000477 — MDI DS-DNA TEST (March 1, 2000)
  • K994029 — MDI SM TEST (January 11, 2000)
  • K993971 — MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN (January 11, 2000)
  • K993636 — MDI SS-A TEST (January 10, 2000)
  • K993635 — MDI SM/RNP TEST (January 10, 2000)
  • K973508 — PYLORI DETECT IGG (March 10, 1998)

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