Phadebas & Phadezyme Rast Allergen Disc

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K830096 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Phadebas Rast Allergen Discs

  Class II

  FDA 510(k) K823841 Active Cleared 12 Jan 1983

• Phadebact Strep F Test

  Class I

  FDA 510(k) K830445 Active Cleared 27 Apr 1983

• Delfia Plate Fluorometer 1232

  Class I

  FDA 510(k) K895240 Active Cleared 4 Oct 1989

• Mastercap Am 5.0/Mastercap Rm 5.0

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  FDA 510(k) K970420 Active Cleared 30 Jun 1997

• Phadebas Igg Rast Test

  Class II

  FDA 510(k) K810694 Active Cleared 23 Jul 1981

• Delfia Progesterone Kit

  Class I

  FDA 510(k) K890428 Active Cleared 23 Feb 1989

See all devices from Pharmacia, Inc. →

• What is the primary function of the Phadebas and Phadezyme Rast Allergen Disc?

  This device is a radioallergosorbent immunological test system designed to serve as a diagnostic tool within the field of immunology.

• What is the regulatory status of this test system?

  The Phadebas and Phadezyme Rast Allergen Disc has received FDA 510(k) clearance under the number K830096 and is classified under regulation number 866.5750.

• Who is the manufacturer of this immunological diagnostic device?

  The device is manufactured by Pharmacia, Inc., which is located in McHenry, Illinois.