FDA 510(k)

SeptiCyte RAPID

K-Number: K232095 · 2023-12-15

Decision Date2023-12-15

Product CodePRE

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SeptiCyte RAPID is the device name listed in this FDA 510(k) record. The listed applicant is Immunexpress, Inc.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K232095. 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 2023-12-15. The listed applicant is Immunexpress, Inc.. The 510(k) number is K232095.

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

SeptiCyte RAPID received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232095.

Who is the listed applicant for SeptiCyte RAPID?

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 RAPID?

The FDA product code for SeptiCyte RAPID 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.

K203748SeptiCyte RAPID K163260SeptiCyte LAB

Related Devices (Code: PRE)

K241676TriVerityInflammatix, Inc.K203748SeptiCyte RAPIDImmunexpress, Inc.K163260SeptiCyte LABImmunexpress, 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.