FDA 510(k)

SeptiCyte LAB

K-Number: K163260 · 2017-02-17

Decision Date2017-02-17

Product CodePRE

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SeptiCyte LAB is the device name listed in this FDA 510(k) record. The listed applicant is Immunexpress, Inc.. It received FDA 510(k) clearance on 2017-02-17 under 510(k) 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. The listed applicant is Immunexpress, Inc.. The 510(k) number is K163260.

When did SeptiCyte LAB receive FDA 510(k) clearance?

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

Who is the listed applicant for SeptiCyte LAB?

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

What is the FDA product code for SeptiCyte LAB?

The FDA product code for SeptiCyte LAB is PRE.

Other records listing Immunexpress, 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.

K232095SeptiCyte RAPID K203748SeptiCyte RAPID

Related Devices (Code: PRE)

K241676TriVerityInflammatix, Inc.K232095SeptiCyte RAPIDImmunexpress, Inc.K203748SeptiCyte RAPIDImmunexpress, 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.