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FDA 510(k)

TAP Blood Collection Device

K-Number: K161521 · 2017-02-16

ApplicantSeventh Sense Biosystems, Inc.
Decision Date2017-02-16
Product CodePRJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TAP Blood Collection Device is a medical device manufactured by Seventh Sense Biosystems, Inc.. It received FDA 510(k) clearance on 2017-02-16 under approval number K161521. 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 2017-02-16. It is manufactured by Seventh Sense Biosystems, Inc.. The 510(k) number is K161521.

When was TAP Blood Collection Device approved by the FDA?

TAP Blood Collection Device received FDA 510(k) clearance on 2017-02-16, under approval number K161521.

What company makes TAP Blood Collection Device?

TAP Blood Collection Device is manufactured by Seventh Sense Biosystems, Inc..

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

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

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) 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 Seventh Sense Biosystems, Inc.

K190225TAP Blood Collection Device

Related Devices (Code: PRJ)

K190225TAP Blood Collection DeviceSeventh Sense Biosystems, Inc.

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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