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510(k) K973882

EL-B2GP1SCR by Theratest Laboratories, Inc. — Product Code MSV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1997
Date Received
October 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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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)
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  • 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)
  • K024151 — EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P (February 6, 2003)
  • K002559 — EL-ANA PROFILES-2K1 (September 12, 2000)

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  • K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY (June 22, 2012)
  • K091556 — HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS (May 21, 2010)
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  • K072032 — IGG ANTI-ATHEROX TEST KIT (April 4, 2008)
  • K062217 — AESKULSKA BETA2-GLYCO-A (December 13, 2006)