FDA 510(k)

Xpert Carba-R

K-Number: K173263 · 2018-01-09

Decision Date2018-01-09

Product CodePOC

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Xpert Carba-R is a medical device manufactured by Cepheid. It received FDA 510(k) clearance on 2018-01-09 under approval number K173263. The device is classified under product code POC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert Carba-R?

Xpert Carba-R is a medical device that received FDA 510(k) clearance on 2018-01-09. It is manufactured by Cepheid. The 510(k) number is K173263.

When was Xpert Carba-R approved by the FDA?

Xpert Carba-R received FDA 510(k) clearance on 2018-01-09, under approval number K173263.

What company makes Xpert Carba-R?

Xpert Carba-R is manufactured by Cepheid.

What is the FDA product code for Xpert Carba-R?

The FDA product code for Xpert Carba-R is POC.

Other Devices by Cepheid

K162444Xpert MRSA NxG K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems K160901Xpert Carba-R K152614Xpert Carba-R K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV K172126Xpert Xpress Strep A

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Related Devices (Code: POC)

K160901Xpert Carba-RCepheid K190613BD MAX Check-Points CPOCheck-Points Health B.V.

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.