Captia(R) Cmv-M
FDA 510(k) K896295 · Mercia Diagnostics , Ltd.
510(k) numberK896295
Submission
- Device name
- Captia(R) Cmv-M
- Applicant
- Mercia Diagnostics , Ltd.
Guildford, Surrey England, GB - Received
- October 31, 1989
- Decision date
- March 6, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
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|---|---|---|---|
| K220949 | Architect CMV IgGLFZ · Traditional | Abbott Laboratories | 10/27/2022SE |
| K220911 | Elecsys CMV IgGLFZ · Traditional | Roche Diagnostics | 10/12/2022SE |
| K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlLFZ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/30/2018SE |
| K163569 | Elecsys CMV IgMLFZ · Traditional | Roche Diagnostics | 03/17/2017SE |
| K162969 | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetLFZ · Special | DiaSorin, Inc. | 01/06/2017SE |
| K142133 | Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmLFZ · Traditional | Roche Diagnostics | 10/24/2014SE |
| K131605 | Elecsys Precicontrol CMV Igg, Elecsys CMV Igg ImmunoassayLFZ · Traditional | Roche Diagnostics | 02/28/2014SE |
| K040290 | Diasorin Liaison CMV Igm/IggLFZ · Traditional | Diasorin S.P.A | 06/01/2005SE |
| K993952 | Immulite 2000 CMV Igg, Model L2KCV2, L2KCV6LFZ · Special | Diagnostic Products Corp. | 12/16/1999SE |
| K982485 | Seraquest CMV IgmLFZ · Traditional | Quest Intl., Inc. | 01/13/1999SE |
More from Quest Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915479 | Captia Cmv-TaLFZ · Traditional | 05/04/1992SE |
| K904524 | Captia(R) Syphilis M, ModificationLIP · Traditional | 12/26/1990SE |
| K900654 | Modified Captia(R) Syphilis-MLIP · Traditional | 03/08/1990SE |
| K900655 | Modified Captia(R) Toxo-MLGD · 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) Cmv-M cleared by the FDA?
Captia(R) Cmv-M (K896295) received a 510(k) decision of Substantially Equivalent on March 6, 1990, 126 days after the submission was received.
What is the product code of K896295?
The FDA product code is LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.