CINtec Histology
K-Number: K212176 · 2021-12-10
ApplicantVentana Medical Systems, Inc.
Decision Date2021-12-10
Product CodePRB
Advisory CommitteePA
DecisionSubstantially Equivalent
Device Summary
CINtec Histology is a medical device manufactured by Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-12-10 under approval number K212176. The device is classified under product code PRB. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CINtec Histology?
CINtec Histology is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Ventana Medical Systems, Inc.. The 510(k) number is K212176.
When was CINtec Histology approved by the FDA?
CINtec Histology received FDA 510(k) clearance on 2021-12-10, under approval number K212176.
What company makes CINtec Histology?
CINtec Histology is manufactured by Ventana Medical Systems, Inc..
What is the FDA product code for CINtec Histology?
The FDA product code for CINtec Histology is PRB.
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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.