Phadirect Strep a Test

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K854150 ↗

FDA Product Code

GTZ

Device Class

Class I

Regulation

21 CFR Part 866.3740

Advisory Committee

Microbiology

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

  Class I

  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. →