Inverness Medical Testpack + Plus Strep a with Obc

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K051638 ↗

FDA Product Code

GTY

FDA applicant

Unipath , Ltd.

Device Class

Class I

Regulation

21 CFR Part 866.3740

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Clearblue Easy

  Class II

  FDA 510(k) K911566 Active Cleared 6 May 1991

• Immunoglobulins G

  Class II

  FDA 510(k) K873870 Active Cleared 13 Oct 1987

• Cefepine Antimicrobial Susceptibility Test Disc

  Class II

  FDA 510(k) K964495 Active Cleared 7 Feb 1997

• Turbox Fibrinogen

  Class II

  FDA 510(k) K884179 Active Cleared 20 Dec 1988

• Clearblue Easy Earliest Results Pregnancy Test

  Class II

  FDA 510(k) K040341 Active Cleared 8 Mar 2004

• Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer

  Class II

  FDA 510(k) K913305 Active Cleared 22 Nov 1991

See all devices from Unipath, Ltd. →