Xpert Carba-R
K-Number: K160901 · 2016-06-29
ApplicantCepheid
Decision Date2016-06-29
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 2016-06-29 under approval number K160901. 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 2016-06-29. It is manufactured by Cepheid. The 510(k) number is K160901.
When was Xpert Carba-R approved by the FDA?
Xpert Carba-R received FDA 510(k) clearance on 2016-06-29, under approval number K160901.
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
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
K162456Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
Related Devices (Code: POC)
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.