510(k) K110923 ยท MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
COBAS 4800 CT / NG TEST
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jan 24, 2012 |
| Received | Apr 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110923
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2014 | Roche Molecular Systems, Inc. cobas PCR Urine Kit 100 PKT IVD
cobas PCR Female Swab Kit 100 PKT IVD
cobas PCR media 100T IVD
cobas PCR Female Swab Kit 100 PKT JPN-IVD
Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA
Roche Terminated |
OOI | None listed |
| Apr 1, 2013 | Roche Diagnostics Operations, Inc. Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/NG 4800 System, for in vitro diagnostics. Terminated |
OOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.