Home / 510(k) Clearances / K925044

510(k) K925044

VENTREX ALLERGEN DISC by Ventrex, Inc. — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1993
Date Received
October 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Device Class
Class II
Regulation Number
866.5750
Review Panel
IM
Submission Type

Other clearances by Ventrex, Inc.

  • K061044 — FEATHERLITE AQUA TOCODYNAMOMETER (July 12, 2006)
  • K013477 — TOCO LITE, MODEL TD-01 (January 17, 2002)
  • K964821 — COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 (July 16, 1997)
  • K963415 — VENTREX OXYGEN SENSOR (November 25, 1996)
  • K924119 — VENTREX ALLERGEN DISC (November 30, 1992)

Other clearances for product code DHB

  • 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)
  • K212181 — ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Alle (August 3, 2022)
  • K220162 — Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, (February 18, 2022)
  • K193613 — Allergen-Specific IgE Assay 12 Allergen Bundle (October 18, 2021)
  • K200825 — NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; (June 26, 2020)
  • K200279 — ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, (May 1, 2020)
  • K191510 — Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, (July 31, 2019)
  • K190315 — ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e23 (May 14, 2019)