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510(k) K993843

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

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)
  • K002359 — MDI GLIADIN G TEST (October 19, 2000)
  • K002358 — MDI GLIADIN A 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)
  • K993635 — MDI SM/RNP TEST (January 10, 2000)
  • K993636 — MDI SS-A TEST (January 10, 2000)
  • K973508 — PYLORI DETECT IGG (March 10, 1998)

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  • 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)