Home / 510(k) Clearances / K982879

510(k) K982879

SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY by Shield Diagnostics, Ltd. — Product Code MSV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1998
Date Received
August 14, 1998
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

Other clearances by Shield Diagnostics, Ltd.

  • K000398 — SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 (April 17, 2000)
  • K980885 — SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY (August 21, 1998)
  • K972981 — SHIELD HELICO-G2 ELISA KIT (March 17, 1998)
  • K962825 — SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY (November 15, 1996)
  • K963525 — DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT (November 7, 1996)
  • K961515 — QUANTASE PHENYLALANINE ASSAY (June 12, 1996)
  • K955303 — DIASTAT ANTI-CARDIOLIPIN KIT (May 30, 1996)
  • K951487 — DIASTAT ANTI-THYROID PEROXIDASE KIT (June 30, 1995)
  • K952183 — DIASTAT ANTI-THYROGLOBULIN KIT (June 30, 1995)
  • K942813 — DIASTAT ANTI-PR3 (C-ANCA) KIT (March 6, 1995)

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  • K152875 — QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar (December 21, 2015)
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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)
  • K092757 — THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR (October 9, 2009)
  • K072032 — IGG ANTI-ATHEROX TEST KIT (April 4, 2008)
  • K062217 — AESKULSKA BETA2-GLYCO-A (December 13, 2006)