MKZ

Dna Probe, Nucleic Acid Amplification, Chlamydia

Product code
MKZ
Device name
Dna Probe, Nucleic Acid Amplification, Chlamydia
Device class
Class 1
21 CFR
21 CFR 866.3120
Medical specialty
Microbiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
19 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-11-16.

NumberDecision dateApplicantDevice nameSummary
K2304512023-11-16Hologic, Inc.Aptima® Chlamydia trachomatis AssayPDF

1 summaries are archived here for direct download.

Official FDA classification page: MKZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).