FDA 510(k) Application Details - K244042

Device Classification Name	Azo Dye, Calcium   More FDA Info for this Device
510(K) Number	K244042
Device Name	Azo Dye, Calcium
Applicant	Abbott Ireland Diagnostic Divison Lisnamuck IE Other 510(k) Applications for this Company
Contact	Cherie Lipowsky Other 510(k) Applications for this Contact
Regulation Number	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2024
Decision Date	02/10/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review