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510(k) K030397

AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA by Hycor Biomedical , Ltd. — Product Code MSV

K030397 is an FDA 510(k) premarket notification submitted by Hycor Biomedical , Ltd. for the device "AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA". The FDA issued a decision of Substantially Equivalent on March 21, 2003. 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. Hycor Biomedical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2003
Date Received
February 6, 2003
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 Hycor Biomedical , Ltd.

  • K261027 — NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture (July 24, 2026)
  • K260591 — NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);C (July 21, 2026)
  • K260280 — NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Cap (June 18, 2026)
  • K260059 — NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excel (May 15, 2026)
  • K252775 — NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Cap (January 16, 2026)
  • K252493 — NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture (December 23, 2025)
  • K242531 — NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum h (April 23, 2025)
  • K220162 — Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, (February 18, 2022)
  • K200825 — NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; (June 26, 2020)
  • K191510 — Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, (July 31, 2019)

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