510(k) K121710 ยท LSL Dna-Reagents, Neisseria
XPERT CT/NG
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 27, 2012 |
| Received | Jun 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121710
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2017 | Cepheid Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157.
Is a qualitative in vitro real-time Terminated |
LSL | None listed |
| Aug 20, 2015 | Cepheid Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit:
Part number CT/NGSWAB-50;
Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, pres Terminated |
LSL | None listed |
| Aug 20, 2015 | Cepheid Xpert CT/NG Urine Specimen Collection Kit
Part number GXCT/NGURINE-50;
Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseri Terminated |
LSL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.