510(k) K170413 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
| Applicant | Bio-Rad Laboratories, Benicia CA, US |
| Decision | Substantially Equivalent, May 11, 2017 |
| Received | Feb 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170413
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2022 | Bio-Rad Laboratories, Inc. BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack Open, Classified |
LIP | None listed |
| Feb 8, 2022 | Bio-Rad Laboratories, Inc. BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL Open, Classified |
LIP | None listed |
| Sep 17, 2021 | Bio-Rad Laboratories, Inc. BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (I Open, Classified |
LIP | None listed |
| Sep 17, 2021 | Bio-Rad Laboratories, Inc. BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RP Open, Classified |
LIP | None listed |
| Apr 21, 2020 | Bio-Rad Laboratories, Inc. BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponem Open, Classified |
LIP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.