Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

66 results for "Cepheid"
25–48 of 66
Cleared May 23, 2019
Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert...
K190441 · QEP
Cepheid
Microbiology · 87d
Cleared May 08, 2019
Cepheid Xpert CT/NG Control Panel
K190223 · PMN
Microbiologics, Inc.
Microbiology · 92d
Cleared Apr 25, 2019
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s...
K190771 · NQX
Cepheid
Microbiology · 30d
Cleared Apr 19, 2019
Cepheid Xpert C. difficile/Epi Control Panel
K190463 · PMN
Microbiologics, Inc.
Microbiology · 52d
Cleared Nov 08, 2018
Cepheid Xpert GBS LB Control Panel
K182472 · PMN
Microbiologics, Inc.
Microbiology · 59d
Cleared Aug 15, 2018
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal...
K181289 · OCC
Cepheid
Microbiology · 91d
Cleared Jul 24, 2018
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal...
K180218 · OCC
Cepheid
Microbiology · 180d
Cleared Apr 26, 2018
Xpert Xpress Strep A
K173398 · PGX
Cepheid
Microbiology · 177d
Cleared Mar 16, 2018
Xpert CT/NG
K173840 · LSL
Cepheid
Microbiology · 88d
Cleared Jan 09, 2018
Xpert Carba-R
K173263 · POC
Cepheid
Microbiology · 90d
Cleared Dec 19, 2017
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal...
K171552 · OCC
Cepheid
Microbiology · 207d
Cleared Sep 25, 2017
Xpert Xpress Strep A
K172126 · PGX
Cepheid
Microbiology · 73d
Cleared Feb 13, 2017
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx...
K162456 · OCC
Cepheid
Microbiology · 164d
Cleared Feb 09, 2017
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert...
K162331 · OCC
Cepheid
Microbiology · 174d
Cleared Nov 23, 2016
Xpert MRSA NxG
K162444 · NQX
Cepheid
Microbiology · 84d
Cleared Aug 29, 2016
Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I,...
K161619 · OUY
Cepheid
Microbiology · 77d
Cleared Jun 29, 2016
Xpert Carba-R
K160901 · POC
Cepheid
Microbiology · 89d
Cleared Mar 07, 2016
Xpert Carba-R
K152614 · PMY
Cepheid
Microbiology · 175d
Cleared Dec 03, 2015
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert...
K151226 · OCC
Cepheid
Microbiology · 210d
Cleared Oct 16, 2015
Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx,...
K151565 · OUY
Cepheid
Microbiology · 128d
Cleared Feb 12, 2015
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert...
K143302 · PEU
Cepheid
Microbiology · 87d
Cleared Nov 26, 2014
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert...
K142501 · PCH
Cepheid
Microbiology · 82d
Cleared Nov 22, 2014
XPERT FLU/RSV XC ASSAY
K142045 · OCC
Cepheid
Microbiology · 117d
Not Cleared Jul 25, 2013
XPERT MTB/RIF ASSAY
DEN130032 · PEU
Cepheid
Microbiology · 44d