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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 2016-09-01 under 510(k) 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. The listed applicant is R&D Systems, Inc.. The 510(k) number is K160606.

When did BC-5D Hematology Control receive FDA 510(k) clearance?

BC-5D Hematology Control received FDA 510(k) clearance on 2016-09-01, under 510(k) number K160606.

Who is the listed applicant for BC-5D Hematology Control?

The FDA 510(k) record lists R&D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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