FDA 510(k)

TAP Blood Collection Device

K-Number: K190225 · 2019-11-05

Decision Date2019-11-05

Product CodePRJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TAP Blood Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Seventh Sense Biosystems, Inc.. It received FDA 510(k) clearance on 2019-11-05 under 510(k) number K190225. The device is classified under product code PRJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAP Blood Collection Device?

TAP Blood Collection Device is a medical device that received FDA 510(k) clearance on 2019-11-05. The listed applicant is Seventh Sense Biosystems, Inc.. The 510(k) number is K190225.

When did TAP Blood Collection Device receive FDA 510(k) clearance?

TAP Blood Collection Device received FDA 510(k) clearance on 2019-11-05, under 510(k) number K190225.

Who is the listed applicant for TAP Blood Collection Device?

The FDA 510(k) record lists Seventh Sense Biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TAP Blood Collection Device?

The FDA product code for TAP Blood Collection Device is PRJ.

Other records listing Seventh Sense Biosystems, Inc. as applicant

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.

K161521TAP Blood Collection Device

Related Devices (Code: PRJ)

K161521TAP Blood Collection DeviceSeventh Sense Biosystems, Inc.

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.