FDA 510(k) Applications Submitted by Yi-Ping Lin
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190076 |
01/16/2019 |
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems |
Cepheid |
| K180218 |
01/25/2018 |
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV |
Cepheid |
| K190441 |
02/25/2019 |
Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit |
Cepheid |
| K190771 |
03/26/2019 |
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
Cepheid |
| K181289 |
05/16/2018 |
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System |
Cepheid |
| K171552 |
05/26/2017 |
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV |
Cepheid |
| K172126 |
07/14/2017 |
Xpert Xpress Strep A |
Cepheid |
| K173263 |
10/11/2017 |
Xpert Carba-R |
Cepheid |
| K173398 |
10/31/2017 |
Xpert Xpress Strep A |
Cepheid |
| K203429 |
11/20/2020 |
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System |
Cepheid |
| K173840 |
12/18/2017 |
Xpert CT/NG |
Cepheid |
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