Ebv-Vca Antibody Assay Kit
FDA 510(k) K821849 · Biotech Research Laboratories, Inc.
510(k) numberK821849
Submission
- Device name
- Ebv-Vca Antibody Assay Kit
- Applicant
- Biotech Research Laboratories, Inc.
Walker, MI, US - Received
- June 23, 1982
- Decision date
- August 12, 1982
- 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 |
| K884829 | Ebv Early Antigen (R+D)JRY · Traditional | Hillcrest Biologicals | 04/12/1989SE |
| K822734 | Ebv Igm TestJRY · Traditional | Gull Laboratories, Inc. | 12/09/1982SE |
| K822985 | Ebv-M KitJRY · Traditional | Litton Bionetics | 12/03/1982SE |
| 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 |
|---|---|---|
| K853484 | Indirect Enzyme Linked Immunosorbent Assay Igg AntGNP · Traditional | 02/05/1986SE |
Questions and answers
When was Ebv-Vca Antibody Assay Kit cleared by the FDA?
Ebv-Vca Antibody Assay Kit (K821849) received a 510(k) decision of Substantially Equivalent on August 12, 1982, 50 days after the submission was received.
What is the product code of K821849?
The FDA product code is JRY – Antiserum, Fluorescent, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.