FDA 510(k) Application Details - K230451

Device Classification Name	Dna Probe, Nucleic Acid Amplification, Chlamydia   More FDA Info for this Device
510(K) Number	K230451
Device Name	Dna Probe, Nucleic Acid Amplification, Chlamydia
Applicant	Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Jon Kukowski Other 510(k) Applications for this Contact
Regulation Number	866.3120   More FDA Info for this Regulation Number
Classification Product Code	MKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2023
Decision Date	11/16/2023
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