FDA 510(k) Application Details - K242872

Device Classification Name	Reagent, Borrelia Serological Reagent   More FDA Info for this Device
510(K) Number	K242872
Device Name	Reagent, Borrelia Serological Reagent
Applicant	ID-FISH Technology, Inc. 556 Gibraltar Drive Milpitas, CA 95035 US Other 510(k) Applications for this Company
Contact	Jyotsna Shah Other 510(k) Applications for this Contact
Regulation Number	866.3830   More FDA Info for this Regulation Number
Classification Product Code	LSR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2024
Decision Date	06/12/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review