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510(k) K100499

ORGENTEC RHEUMATOID FACTOR EIA by Orgentec Diagnostika GmbH — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2010
Date Received
February 22, 2010
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 Orgentec Diagnostika GmbH

  • K092399 — ANTI-MUTATED CITRULLINATED VIMENTIN EIA (July 1, 2010)
  • K030929 — ANA DETECT (May 2, 2003)

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