Quantra
K-Number: K163623 · 2017-10-20
ApplicantHologic, Inc.
Decision Date2017-10-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Quantra is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2017-10-20 under approval number K163623. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Quantra?
Quantra is a medical device that received FDA 510(k) clearance on 2017-10-20. It is manufactured by Hologic, Inc.. The 510(k) number is K163623.
When was Quantra approved by the FDA?
Quantra received FDA 510(k) clearance on 2017-10-20, under approval number K163623.
What company makes Quantra?
Quantra is manufactured by Hologic, Inc..
What is the FDA product code for Quantra?
The FDA product code for Quantra is LLZ.
Other Devices by Hologic, Inc.
K153486Affirm Prone Biopsy System
K172629Panther Fusion AdV/hMPV/RV Assay
K172282Panther Fusion Paraflu Assay
K171963Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K162673Aptima Herpes Simplex Viruses 1 & 2 Assay
Related Devices (Code: LLZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.