Prospect(Tm) Giardia Microtiter Assay/Modification

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

510(k) Number

K922010 ↗

FDA Product Code

MHI

Device Class

Class II

Regulation

21 CFR Part 866.3220

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Prospect(Tm/Cryptosporidium

  Class II

  FDA 510(k) K912242 Active Cleared 23 Mar 1992

• Prospect Microplate Assay

  Class I

  FDA 510(k) K934493 Active Cleared 20 Sep 1994

• Prospec T/Giardia Rapid Assay

  Class II

  FDA 510(k) K911337 Active Cleared 27 Sep 1991

• Prospect(Tm) Giardia Rapid Assay, Modification

  Class II

  FDA 510(k) K931147 Active Cleared 13 May 1993

• Modification Prospect Giardia Rapid Assay

  Class II

  FDA 510(k) K920817 Active Cleared 22 Apr 1992

• Prospec T Giardia Microtiter Assay

  Class II

  FDA 510(k) K930451 Active Cleared 21 Apr 1993

See all devices from Alexon, Inc. →