Ebv Early Antigen (R+D)
FDA 510(k) K884829 · Hillcrest Biologicals
510(k) numberK884829
Submission
- Device name
- Ebv Early Antigen (R+D)
- Applicant
- Hillcrest Biologicals
Cypress, CA, US - Received
- November 18, 1988
- Decision date
- April 12, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JRY – Antiserum, Fluorescent, Epstein-Barr Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
Other 510(k)s with product code JRY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042118 | Athena Multi-Lyte Ebv Igg Test SystemJRY · Traditional | Zeus Scientific, Inc. | 04/29/2005SE |
| K900974 | Indirect Fluorescent Assay for (Ebv-Vca) Igg Anti.JRY · Traditional | Stellar Bio Systems, Inc. | 04/16/1990SE |
| K891785 | Bion Ebv-G (Vca) Test SystemJRY · Traditional | Bion Ent., Ltd. | 08/31/1989SE |
| K822734 | Ebv Igm TestJRY · Traditional | Gull Laboratories, Inc. | 12/09/1982SE |
| K822985 | Ebv-M KitJRY · Traditional | Litton Bionetics | 12/03/1982SE |
| K821849 | Ebv-Vca Antibody Assay KitJRY · Traditional | Biotech Research Laboratories, Inc. | 08/12/1982SE |
| K811262 | Epstein-Barr Virus Capsid Antigen AntiJRY · Traditional | Zeus Scientific, Inc. | 05/27/1981SE |
| K780925 | Eb-Vca, Test, Antibody, FluorescentJRY · Traditional | Litton Bionetics | 06/22/1978SE |
More from Litton Bionetics
| 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 |
| K896594 | Ebv Vca Antibody (Igm)LJN · Traditional | 01/16/1990SE |
| 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 Early Antigen (R+D) cleared by the FDA?
Ebv Early Antigen (R+D) (K884829) received a 510(k) decision of Substantially Equivalent on April 12, 1989, 145 days after the submission was received.
What is the product code of K884829?
The FDA product code is JRY – Antiserum, Fluorescent, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.