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510(k) K024151

EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P by Theratest Laboratories, Inc. — Product Code MQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2003
Date Received
December 6, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Ribosomal P Antibodies
Device Class
Class II
Regulation Number
866.5100
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)
  • K024031 — THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE (February 6, 2003)
  • K002559 — EL-ANA PROFILES-2K1 (September 12, 2000)
  • K982622 — EL-ANA PROFILES: EL-ENA/5 (August 13, 1998)

Other clearances for product code MQA

  • K202540 — EliA Rib-P (September 13, 2021)
  • K981237 — QUANTA LITE RIBOSOME P ELISA (June 5, 1998)
  • K950169 — RIBOSOMAL P EIA TEST SYSTEM (May 23, 1996)