Ebv Vca Antibody (Igm)
FDA 510(k) K896594 · Hillcrest Biologicals
510(k) numberK896594
Submission
- Device name
- Ebv Vca Antibody (Igm)
- Applicant
- Hillcrest Biologicals
Cypress, CA, US - Received
- November 21, 1989
- Decision date
- January 16, 1990
- 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 |
|---|---|---|
| K913618 | Arbovirus Igm Ifa TestGQC · Traditional | 12/03/1992SE |
| K913617 | Arbovirus Igg Ifa TestGQC · Traditional | 12/03/1992SE |
| K922374 | Q Fever Igm Ifa TestGPJ · Traditional | 10/21/1992SE |
| K913906 | Q Fever Igg Ifa TestGPJ · Traditional | 10/21/1992SE |
| K900206 | Lyme Disease Igm ElisaLSR · Traditional | 06/28/1991SE |
| K884829 | Ebv Early Antigen (R+D)JRY · Traditional | 04/12/1989SE |
| K883767 | Lyme Disease Ifa (Igm)LSR · Traditional | 03/15/1989SE |
| K884591 | Ebv-Vca Antibody (Igg)GNP · Traditional | 01/24/1989SE |
| K883487 | Lyme Disease Ifa (Igg)LSR · Traditional | 12/13/1988SE |
| K875170 | Ebna AntibodyLLM · Traditional | 05/23/1988SE |
Questions and answers
When was Ebv Vca Antibody (Igm) cleared by the FDA?
Ebv Vca Antibody (Igm) (K896594) received a 510(k) decision of Substantially Equivalent on January 16, 1990, 56 days after the submission was received.
What is the product code of K896594?
The FDA product code is LJN – Antibody Igm, If, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.