Seraquest Eb Vac Igm
FDA 510(k) K990977 · Quest Intl., Inc.
510(k) numberK990977
Submission
- Device name
- Seraquest Eb Vac Igm
- Applicant
- Quest Intl., Inc.
North Miami, FL, US - Received
- March 23, 1999
- Decision date
- October 6, 1999
- 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 |
| 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 |
| K915348 | Ebv-Vca Igm ElisaLJN · Traditional | Pharmacia Diagnostics, Inc. | 02/14/1992SE |
More from Pharmacia Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K091260 | Seraquest Ebv Ea-D Igg TestLSE · Traditional | 06/08/2009SE |
| K033915 | Modification to Seraquest Eb Vca IggLSE · Special | 01/16/2004SE |
| K033780 | Modification to Seraquest Vca IgmLJN · Special | 01/15/2004SE |
| K023593 | Seraquest Anti-Thyroid Peroxidase (Tpo)JZO · Traditional | 02/06/2003SE |
| K023592 | Seraquest Anti-ThyroglobulinDDC · Traditional | 01/06/2003SE |
| K003069 | Anti-Cardiolipin, Multiple Autoantibodies Immunological Test SystemMID · Traditional | 11/27/2000SE |
| K991975 | Seraquest Eb Na IggLSE · Traditional | 11/02/1999SE |
| K990410 | Seraquest Eb Vca IggLSE · Traditional | 10/28/1999SE |
| K982485 | Seraquest CMV IgmLFZ · Traditional | 01/13/1999SE |
| K982281 | Seraquest Rubella IgmLFX · Traditional | 10/16/1998SE |
Questions and answers
When was Seraquest Eb Vac Igm cleared by the FDA?
Seraquest Eb Vac Igm (K990977) received a 510(k) decision of Substantially Equivalent on October 6, 1999, 197 days after the submission was received.
What is the product code of K990977?
The FDA product code is LJN – Antibody Igm, If, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.