Captia(R) Syphilis M, Modification
FDA 510(k) K904524 · Mercia Diagnostics , Ltd.
510(k) numberK904524
Submission
- Device name
- Captia(R) Syphilis M, Modification
- Applicant
- Mercia Diagnostics , Ltd.
Guildford, Surrey England, GB - Received
- September 27, 1990
- Decision date
- December 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIP – Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Specialty
- Microbiology
Other 510(k)s with product code LIP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241427 | Access SyphilisLIP · Traditional | Beckman Coulter, Inc. | 09/06/2024SE |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent PackLIP · Traditional | Ortho Clinical Diagnostics | 08/28/2024SE |
| K211302 | Elecsys SyphilisLIP · Traditional | Roche Diagnostics | 07/20/2021SE |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set…LIP · Traditional | Bio-Rad Laboratories | 05/11/2017SE |
| K160910 | Elecsys SyphilisLIP · Traditional | Roche Diagnostics | 07/28/2016SE |
| K153145 | Lumipulse G TP-N Immunoreaction Cartridge SetLIP · Traditional | Fujirebio Diagnostics,Inc. | 07/05/2016SE |
| K153730 | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP…LIP · Traditional | Abbott Laboratories | 06/15/2016SE |
| K120439 | Bioplex 2200 Ebv Igg and Syphilis IggLIP · Special | Bio-Rad Laboratories, Inc. | 03/14/2012SE |
| K112343 | Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsLIP · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/20/2012SE |
| K102400 | Syphilis Health CheckLIP · Traditional | Diagnostics Direct, LLC | 08/01/2011SE |
More from Diagnostics Direct, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K915479 | Captia Cmv-TaLFZ · Traditional | 05/04/1992SE |
| K900654 | Modified Captia(R) Syphilis-MLIP · Traditional | 03/08/1990SE |
| K900655 | Modified Captia(R) Toxo-MLGD · Traditional | 03/06/1990SE |
| K896295 | Captia(R) Cmv-MLFZ · Traditional | 03/06/1990SE |
| K896194 | Captia(R) Cmv-GLFZ · Traditional | 03/06/1990SE |
| K885300 | Captia(R) Rubella-MLFX · Traditional | 08/15/1989SE |
| K883924 | Captia(R) Rubella-GLFX · Traditional | 08/15/1989SE |
| K892802 | Super DuoJWZ · Traditional | 06/13/1989SE |
| K881425 | Captia(R) Syphilis-GLIP · Traditional | 08/04/1988SE |
| K880918 | Captia Toxo-GLGD · Traditional | 08/01/1988SE |
Questions and answers
When was Captia(R) Syphilis M, Modification cleared by the FDA?
Captia(R) Syphilis M, Modification (K904524) received a 510(k) decision of Substantially Equivalent on December 26, 1990, 90 days after the submission was received.
What is the product code of K904524?
The FDA product code is LIP – Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, a Class II (moderate risk) device regulated under 21 CFR 866.3830.