hemochroma PLUS System
K-Number: K163465 · 2017-09-08
ApplicantImmunostics Inc.,
Decision Date2017-09-08
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
hemochroma PLUS System is a medical device manufactured by Immunostics Inc.,. It received FDA 510(k) clearance on 2017-09-08 under approval number K163465. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the hemochroma PLUS System?
hemochroma PLUS System is a medical device that received FDA 510(k) clearance on 2017-09-08. It is manufactured by Immunostics Inc.,. The 510(k) number is K163465.
When was hemochroma PLUS System approved by the FDA?
hemochroma PLUS System received FDA 510(k) clearance on 2017-09-08, under approval number K163465.
What company makes hemochroma PLUS System?
hemochroma PLUS System is manufactured by Immunostics Inc.,.
What is the FDA product code for hemochroma PLUS System?
The FDA product code for hemochroma PLUS System is GKR.
Other Devices by Immunostics Inc.,
Related Devices (Code: GKR)
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.