HSV-1 Elisa Igg, Model EL0910G
FDA 510(k) K993754 · Mrl Diagnostics
510(k) numberK993754
Submission
- Device name
- HSV-1 Elisa Igg, Model EL0910G
- Applicant
- Mrl Diagnostics
Cypress, CA, US - Received
- November 5, 1999
- Decision date
- February 9, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXJ – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code MXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsMXJ · Traditional | Biokit, S.A. | 09/20/2023SE |
| K220923 | Elecsys HSV-1 IgG (08948844160)MXJ · Traditional | Roche Diagnostics | 10/12/2022SE |
| K181333 | ADVIA Centaur Herpes-1 IgGMXJ · Traditional | Biokit, S.A. | 08/23/2018SE |
| K162276 | SeraQuest Herpes Type 1 Specific IgGMXJ · Traditional | Quest International, Inc. | 10/01/2016SE |
| K143236 | Theranos Herpes Simplex Virus-1 IgG AssayMXJ · Traditional | Theranos, Inc. | 07/02/2015SE |
| K131334 | Herpes Simplex Virus Type 1 Igg Elisa TestMXJ · Traditional | Gold Standard Diagnostics | 02/28/2014SE |
| K120625 | Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVMXJ · Traditional | Roche Diagnostics | 07/25/2012SE |
| K120959 | Bioplex 2200 HSV-1 and HSV-2 Igg KitMXJ · Traditional | Bio-Rad Laboratories | 06/22/2012SE |
| K103363 | Zeus Elisa HSV Gc-I Igg Test SystemMXJ · Traditional | Zeus Scientific, Inc. | 04/26/2011SE |
| K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection SystemMXJ · Traditional | Bio-Rad Laboratories | 05/08/2009SE |
More from Bio-Rad Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GLGC · Traditional | 04/14/2000SE |
| K993724 | HSV-2 Elisa Igg, Model EL0920GMYF · Traditional | 02/01/2000SE |
| K971007 | Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M)LSR · Traditional | 06/01/1998SE |
| K971006 | Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G)LSR · Traditional | 06/01/1998SE |
| K946353 | Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent AssayLLM · Traditional | 07/21/1995SE |
| K931520 | Epstein-Barr Virus Vca (Igm) Recomb Immun AntibodyLJN · Traditional | 04/26/1994SE |
Questions and answers
When was HSV-1 Elisa Igg, Model EL0910G cleared by the FDA?
HSV-1 Elisa Igg, Model EL0910G (K993754) received a 510(k) decision of Substantially Equivalent on February 9, 2000, 96 days after the submission was received.
What is the product code of K993754?
The FDA product code is MXJ – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1, a Class II (moderate risk) device regulated under 21 CFR 866.3305.