Panbio Indx Igm Dip-S-Ticks Leptospirosis Test for the Detection of Igm Antibodies to Leptospira Biflexa

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K002024 ↗

FDA Product Code

GRY

Device Class

Class II

Regulation

21 CFR Part 866.3350

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Tpp

  Class II

  FDA 510(k) K962176 Active Cleared 18 Oct 1996

• West Nile Virus Igm Capture Elisa

  Class II

  FDA De Novo DEN030004 Active Cleared 8 Jul 2003 FDA 510(k)

• Abs Cadkit

  Class II

  FDA 510(k) K910636 Active Cleared 29 Apr 1991

• Ebv Vca-P18 Igg Elisa

  Class I

  FDA 510(k) K030863 Active Cleared 27 Jun 2003

• West Nile Virus Igm Capture Elisa, Model E-WNV02M

  Class II

  FDA 510(k) K041231 Active Cleared 10 Aug 2004

• Fif Tm

  Class II

  FDA 510(k) K970189 Active Cleared 21 May 1997

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