BC-5390 Auto Hematology Analyzer
K-Number: K160429 · 2016-09-01
Decision Date2016-09-01
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
BC-5390 Auto Hematology Analyzer is a medical device manufactured by Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-09-01 under approval number K160429. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BC-5390 Auto Hematology Analyzer?
BC-5390 Auto Hematology Analyzer is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K160429.
When was BC-5390 Auto Hematology Analyzer approved by the FDA?
BC-5390 Auto Hematology Analyzer received FDA 510(k) clearance on 2016-09-01, under approval number K160429.
What company makes BC-5390 Auto Hematology Analyzer?
BC-5390 Auto Hematology Analyzer is manufactured by Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for BC-5390 Auto Hematology Analyzer?
The FDA product code for BC-5390 Auto Hematology Analyzer is GKZ.
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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.