510(k) K170413
- Device
- BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
- Applicant
- Bio-Rad Laboratories
- 510(k) number
- K170413
- Product code
- LIP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-05-11
- Date received
- 2017-02-10
- Regulation
- 866.3830
- Classification name
- Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Juang Wang
- Address
- 5500 E. 2nd St. Benicia CA US 94510 94510
FDA Registration Numbers#
- 8023060
- 3026565854
- 2242436
- 2432235
- 3005333358
- 3032705
- 3022178699
- 3002806944
- 3011989923
- 3002809144
- 9610240
- 2029372
- 9610126
- 3005360469
- 1318354
- 2122870
- 3002895169
- 2915274
- 3009178048
- 2431980
- 2182595
- 1641328
- 3000254998
- 1219913
- 1319681
Source Documents#
Other 510(k) Records For Product Code LIP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241427 | Access Syphilis | Beckman Coulter, Inc. | 2024-09-06 |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | Ortho Clinical Diagnostics | 2024-08-28 |
| K211302 | Elecsys Syphilis | Roche Diagnostics | 2021-07-20 |
| K160910 | Elecsys Syphilis | Roche Diagnostics | 2016-07-28 |
| K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | Fujirebio Diagnostics,Inc. | 2016-07-05 |
| K153730 | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control | Abbott Laboratories | 2016-06-15 |
| K120439 | BIOPLEX 2200 EBV IGG AND SYPHILIS IGG | Bio-Rad Laboratories, Inc. | 2012-03-14 |
| K112343 | TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 |
| K102400 | SYPHILIS HEALTH CHECK | Diagnostics Direct, LLC | 2011-08-01 |
| K102283 | ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM | Zeus Scientific, Inc. | 2011-02-10 |
| K093837 | ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM | Zeus Scientific, Inc. (Zeus) | 2010-10-01 |
| K091361 | IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM | Siemens Healthcare Diagnostics | 2009-12-16 |
| K063866 | BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | 2007-03-19 |
| K050590 | ENZY-WELL SYPHILIS IGG, MODEL 91106 | Diesse Diagnostica Senese S.P.A. | 2006-08-10 |
| K053570 | TREP-SURE TREPONEMAL ANTIBODY EIA | Phoenix Biotech Corp. | 2006-08-07 |
Legacy Summary#
summary
FDA Review#
Decision Summary