510(k) K992552
- Device
- COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
- Applicant
- DIASORIN, INC.
- 510(k) number
- K992552
- Product code
- LIP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-12-16
- Date received
- 1999-07-30
- 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
- JUDITH J SMITH
- Address
- 9175 Guiford Rd. Columbia MD US 21046 21046
FDA Registration Numbers#
- 3032705
- 3005360469
- 3005333358
- 2432235
- 3022178699
- 3026565854
- 1641328
- 2915274
- 3002809144
- 2182595
- 2431980
- 1318354
- 3009178048
- 2122870
- 3002895169
- 3011989923
- 3000254998
- 2242436
- 8023060
- 1219913
- 9610240
- 9610126
- 2029372
- 1319681
- 3002806944
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 |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set | Bio-Rad Laboratories | 2017-05-11 |
| 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 |
Legacy Summary#
summary
FDA Review#
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