BC-5D Hematology Control
K-Number: K160606 · 2016-09-01
ApplicantR&D Systems, Inc.
Decision Date2016-09-01
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
BC-5D Hematology Control is a medical device manufactured by R&D Systems, Inc.. It received FDA 510(k) clearance on 2016-09-01 under approval number K160606. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BC-5D Hematology Control?
BC-5D Hematology Control is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by R&D Systems, Inc.. The 510(k) number is K160606.
When was BC-5D Hematology Control approved by the FDA?
BC-5D Hematology Control received FDA 510(k) clearance on 2016-09-01, under approval number K160606.
What company makes BC-5D Hematology Control?
BC-5D Hematology Control is manufactured by R&D Systems, Inc..
What is the FDA product code for BC-5D Hematology Control?
The FDA product code for BC-5D Hematology Control is JPK.
Related Devices (Code: JPK)
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.