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FDA 510(k)

Kawasumi Laboratories Blood Drawing Kit (BDK) System

K-Number: K172957 · 2018-09-28

ApplicantKawasumi Laboratories, Inc.
Decision Date2018-09-28
Product CodeKSB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Kawasumi Laboratories Blood Drawing Kit (BDK) System is a medical device manufactured by Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2018-09-28 under approval number K172957. The device is classified under product code KSB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kawasumi Laboratories Blood Drawing Kit (BDK) System?

Kawasumi Laboratories Blood Drawing Kit (BDK) System is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Kawasumi Laboratories, Inc.. The 510(k) number is K172957.

When was Kawasumi Laboratories Blood Drawing Kit (BDK) System approved by the FDA?

Kawasumi Laboratories Blood Drawing Kit (BDK) System received FDA 510(k) clearance on 2018-09-28, under approval number K172957.

What company makes Kawasumi Laboratories Blood Drawing Kit (BDK) System?

Kawasumi Laboratories Blood Drawing Kit (BDK) System is manufactured by Kawasumi Laboratories, Inc..

What is the FDA product code for Kawasumi Laboratories Blood Drawing Kit (BDK) System?

The FDA product code for Kawasumi Laboratories Blood Drawing Kit (BDK) System is KSB.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Kawasumi Laboratories, Inc.

K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) K190233K-Shield Advantage Port Access Infusion Set (PAIS)

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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