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510(k) K962050

THERATEST EL-RFSCR by Theratest Laboratories, Inc. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1996
Date Received
May 28, 1996
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 Theratest Laboratories, Inc.

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  • K071692 — THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS (November 5, 2007)
  • K061376 — EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 (July 20, 2006)
  • K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (February 7, 2006)
  • K051066 — THERATEST EL-ANA PROFILES (October 7, 2005)
  • K040291 — EL-ANA PROFILES: ANTI-CHROMATIN (March 11, 2004)
  • K024151 — EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P (February 6, 2003)
  • K024031 — THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE (February 6, 2003)
  • K002559 — EL-ANA PROFILES-2K1 (September 12, 2000)

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