Epstein-Barr Virus Vca (Igm) Recomb Immun Antibody
FDA 510(k) K931520 · Mrl Diagnostics
510(k) numberK931520
Submission
- Device name
- Epstein-Barr Virus Vca (Igm) Recomb Immun Antibody
- Applicant
- Mrl Diagnostics
Cypress, CA, US - Received
- March 26, 1993
- Decision date
- April 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJN – Antibody Igm, If, Epstein-Barr Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
Other 510(k)s with product code LJN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123021 | Bioplex 2200 Ebv Igm KitLJN · Traditional | Bio-Rad Laboratories | 11/02/2012SE |
| K073381 | Plexus Ebv Igm Multi-Analyte Diagnostics, Model: MP0600MLJN · Traditional | Focus Diagnostics, Inc. | 08/04/2008SE |
| K042092 | Athena Multi-Lyte Ebv Vca Igm Test SystemLJN · Traditional | Zeus Scientific, Inc. | 04/12/2005SE |
| K033780 | Modification to Seraquest Vca IgmLJN · Special | Quest Intl., Inc. | 01/15/2004SE |
| K990977 | Seraquest Eb Vac IgmLJN · Traditional | Quest Intl., Inc. | 10/06/1999SE |
| K991459 | Copalis Ebv-M Antibody AssayLJN · Traditional | DiaSorin, Inc. | 05/14/1999SE |
| K973939 | Immunowell Vca Igm TestLJN · Traditional | Genbio | 08/10/1998SE |
| K930020 | Ortho*Epstein-Barr Virus Vca-Igm Antibody ElisaLJN · Traditional | Ortho Diagnostic Systems, Inc. | 07/16/1993SE |
| K922331 | Bartels Epstein-Barr Virus Igm EiaLJN · Traditional | Baxter Diagnostics, Inc. | 09/02/1992SE |
| K915348 | Ebv-Vca Igm ElisaLJN · Traditional | Pharmacia Diagnostics, Inc. | 02/14/1992SE |
More from Pharmacia Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GLGC · Traditional | 04/14/2000SE |
| K993754 | HSV-1 Elisa Igg, Model EL0910GMXJ · Traditional | 02/09/2000SE |
| 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 |
Questions and answers
When was Epstein-Barr Virus Vca (Igm) Recomb Immun Antibody cleared by the FDA?
Epstein-Barr Virus Vca (Igm) Recomb Immun Antibody (K931520) received a 510(k) decision of Substantially Equivalent on April 26, 1994, 396 days after the submission was received.
What is the product code of K931520?
The FDA product code is LJN – Antibody Igm, If, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.