Ebv Igm Elisa Test
FDA 510(k) K910042 · Gull Laboratories, Inc.
510(k) numberK910042
Submission
- Device name
- Ebv Igm Elisa Test
- Applicant
- Gull Laboratories, Inc.
Salt Lake City, UT, US - Received
- January 4, 1991
- Decision date
- February 21, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K931520 | Epstein-Barr Virus Vca (Igm) Recomb Immun AntibodyLJN · Traditional | Mrl Diagnostics | 04/26/1994SE |
| 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 |
More from Baxter Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983541 | HSV 1+2 Igg Elisa TestLGC · Traditional | 02/26/1999SE |
| K971857 | Mumps Igg Elisa TestyLJY · Traditional | 11/04/1997SE |
| K962343 | Toxo Igg Elisa TestLGD · Traditional | 03/24/1997SE |
| K935730 | Ebna Igg Elisa TestLLM · Traditional | 09/19/1995SE |
| K940093 | Ebv-Ea(D) Igg Elisa TestLSE · Traditional | 09/15/1995SE |
| K941046 | VZV Igg Elisa TestLFY · Traditional | 08/24/1995SE |
| K941198 | Ebv LGG Elisa TestLSE · Traditional | 08/23/1995SE |
| K932333 | Protectoral Ultrasonic Handpiece ProcessorEFB · Traditional | 08/15/1995SE |
| K941624 | Rubella Igg Elisa TestLFX · Traditional | 08/04/1995SE |
| K922759 | HSV-2 Igm Elisa Test--ModificationLGC · Traditional | 10/05/1992SE |
Questions and answers
When was Ebv Igm Elisa Test cleared by the FDA?
Ebv Igm Elisa Test (K910042) received a 510(k) decision of Substantially Equivalent on February 21, 1991, 48 days after the submission was received.
What is the product code of K910042?
The FDA product code is LJN – Antibody Igm, If, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.