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FDA 510(k)

SeptiCyte RAPID

K-Number: K203748 · 2021-11-29

ApplicantImmunexpress, Inc.
Decision Date2021-11-29
Product CodePRE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SeptiCyte RAPID is a medical device manufactured by Immunexpress, Inc.. It received FDA 510(k) clearance on 2021-11-29 under approval number K203748. The device is classified under product code PRE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeptiCyte RAPID?

SeptiCyte RAPID is a medical device that received FDA 510(k) clearance on 2021-11-29. It is manufactured by Immunexpress, Inc.. The 510(k) number is K203748.

When was SeptiCyte RAPID approved by the FDA?

SeptiCyte RAPID received FDA 510(k) clearance on 2021-11-29, under approval number K203748.

What company makes SeptiCyte RAPID?

SeptiCyte RAPID is manufactured by Immunexpress, Inc..

What is the FDA product code for SeptiCyte RAPID?

The FDA product code for SeptiCyte RAPID is PRE.

Other Devices by Immunexpress, Inc.

K163260SeptiCyte LAB K232095SeptiCyte RAPID

Related Devices (Code: PRE)

K163260SeptiCyte LABImmunexpress, Inc. K232095SeptiCyte RAPIDImmunexpress, Inc. K241676TriVerityInflammatix, 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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