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FDA 510(k)

BC-3200 AUTO HEMATOLOGY ANALYZER

K-Number: K063407 · 2007-06-11

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2007-06-11
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BC-3200 AUTO HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2007-06-11 under 510(k) number K063407. 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-3200 AUTO HEMATOLOGY ANALYZER?

BC-3200 AUTO HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 2007-06-11. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K063407.

When did BC-3200 AUTO HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

BC-3200 AUTO HEMATOLOGY ANALYZER received FDA 510(k) clearance on 2007-06-11, under 510(k) number K063407.

Who is the listed applicant for BC-3200 AUTO HEMATOLOGY ANALYZER?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BC-3200 AUTO HEMATOLOGY ANALYZER?

The FDA product code for BC-3200 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.

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