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FDA 510(k)

SeptiCyte LAB

K-Number: K163260 · 2017-02-17

ApplicantImmunexpress, Inc.
Decision Date2017-02-17
Product CodePRE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SeptiCyte LAB is a medical device manufactured by Immunexpress, Inc.. It received FDA 510(k) clearance on 2017-02-17 under approval number K163260. 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 LAB?

SeptiCyte LAB is a medical device that received FDA 510(k) clearance on 2017-02-17. It is manufactured by Immunexpress, Inc.. The 510(k) number is K163260.

When was SeptiCyte LAB approved by the FDA?

SeptiCyte LAB received FDA 510(k) clearance on 2017-02-17, under approval number K163260.

What company makes SeptiCyte LAB?

SeptiCyte LAB is manufactured by Immunexpress, Inc..

What is the FDA product code for SeptiCyte LAB?

The FDA product code for SeptiCyte LAB is PRE.

Other Devices by Immunexpress, Inc.

K203748SeptiCyte RAPID K232095SeptiCyte RAPID

Related Devices (Code: PRE)

K203748SeptiCyte RAPIDImmunexpress, 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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