Aptima Mycoplasma genitalium Assay— 510(k) DEN180047

Unknown

Hologic, Inc.

FDA 510(k) clearance DEN180047 for Aptima Mycoplasma genitalium Assay, Unknown on 2019-01-23. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code QEP
Device class: Class 2
Regulation: 21 CFR 866.3393
Advisory panel: Microbiology
Date received: 2018-08-31
Decision date: 2019-01-23
Decision: Unknown
Clearance type: Direct
Location: San Diego, CA, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.