Immunowell Vca Igm Test
FDA 510(k) K973939 · Genbio
510(k) numberK973939
Submission
- Device name
- Immunowell Vca Igm Test
- Applicant
- Genbio
San Diego, CA, US - Received
- October 15, 1997
- Decision date
- August 10, 1998
- 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 |
| 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 |
| K915348 | Ebv-Vca Igm ElisaLJN · Traditional | Pharmacia Diagnostics, Inc. | 02/14/1992SE |
More from Pharmacia Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K010301 | Immunowell Ea (D) Igg TestLSE · Traditional | 06/11/2001SE |
| K974244 | Immunodot Mono-M TestLSE · Traditional | 09/22/1998SE |
| K974226 | Immunodot Mono-G TestLSE · Traditional | 09/22/1998SE |
| K973941 | Immunowell Ebna Igg TestLLM · Traditional | 08/10/1998SE |
| K973940 | Immunowell Ebv Vca Igg TestLSE · Traditional | 08/10/1998SE |
| K963054 | Immunowell Mycoplasma Pneumonia Antibody (Igm) Test (3130)LJZ · Traditional | 05/05/1997SE |
| K963055 | Immunowell Mycoplasma Pneumonia Antibody (Igg) Test 3120LJZ · Traditional | 05/02/1997SE |
| K953683 | Mmuno Dot Borrelia Dot Blot M TestLSR · Traditional | 05/03/1996SE |
| K953682 | Immuno Dot Borrelia Dot Blot G TestLSR · Traditional | 05/03/1996SE |
Questions and answers
When was Immunowell Vca Igm Test cleared by the FDA?
Immunowell Vca Igm Test (K973939) received a 510(k) decision of Substantially Equivalent on August 10, 1998, 299 days after the submission was received.
What is the product code of K973939?
The FDA product code is LJN – Antibody Igm, If, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.