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510(k) K013628

DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM by Diamedix Corp. — Product Code MSV

K013628 is an FDA 510(k) premarket notification submitted by Diamedix Corp. for the device "DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on December 21, 2001. The device falls under product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)), a Class II device regulated under 21 CFR 866.5660. Diamedix Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2001
Date Received
November 5, 2001
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 Diamedix Corp.

  • K093101 — MAGO 4S (January 21, 2011)
  • K021394 — DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM (July 9, 2002)
  • K013956 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN (January 8, 2002)
  • K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM (October 26, 2001)
  • K012450 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM (October 26, 2001)
  • K012797 — DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM (September 28, 2001)
  • K012795 — DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM (September 28, 2001)
  • K012053 — DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM (August 20, 2001)
  • K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (November 28, 2000)
  • K001875 — DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM (August 21, 2000)

Other clearances for product code MSV

  • K243979 — Aptiva APS IgA Reagent (February 6, 2026)
  • K181329 — EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (June 25, 2018)
  • K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody (June 19, 2017)
  • K152875 — QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar (December 21, 2015)
  • K141274 — QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTRO (February 13, 2015)
  • 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)

FDA data resources