Modified Ddi Serocard CMV Igg Test Kit
FDA 510(k) K884248 · Disease Detection International, Inc.
510(k) numberK884248
Submission
- Device name
- Modified Ddi Serocard CMV Igg Test Kit
- Applicant
- Disease Detection International, Inc.
Irvine, CA, US - Received
- October 11, 1988
- Decision date
- April 10, 1989
- 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 |
|---|---|---|
| K943252 | Pro-Step LH Ovulation Prediction TestCEP · Traditional | 10/25/1994SE |
| K925303 | Pro-Step PT HCGJHI · Traditional | 06/15/1993SE |
| K925125 | Pro-Step HCGJHI · Traditional | 01/13/1993SE |
| K911826 | Immunocard HCG One Step (I-S) Test KitJHI · Traditional | 07/19/1991SE |
| K902571 | Modification of Serocard Rubella Igg TestLFX · Traditional | 09/05/1990SE |
| K903070 | Serocard HSV Igg Antibody Test KitLGC · Traditional | 08/09/1990SE |
| K895912 | Immunocard HCG Ii-S Test KitJHI · Traditional | 12/01/1989SE |
| K896109 | Immunocard Strep a TestGTZ · Traditional | 11/29/1989SE |
| K884249 | Modified Ddi Serocard Toxoplasma Igg Test KitLGD · Traditional | 04/10/1989SE |
| K884247 | Modified Ddi Serocard Rubella Igg Test KitLFX · Traditional | 04/10/1989SE |
Questions and answers
When was Modified Ddi Serocard CMV Igg Test Kit cleared by the FDA?
Modified Ddi Serocard CMV Igg Test Kit (K884248) received a 510(k) decision of Substantially Equivalent on April 10, 1989, 181 days after the submission was received.
What is the product code of K884248?
The FDA product code is LFZ – Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.