K230451
- 510(k) number
- K230451
- Device name
- Aptima® Chlamydia trachomatis Assay
- Applicant
- Hologic, Inc. CA · US
- Product code
- MKZ — Dna Probe, Nucleic Acid Amplification, Chlamydia
- Decision date
- 2023-11-16
- Date received
- 2023-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230451.pdf
Official FDA record: K230451
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.