Ebv Igm Test
FDA 510(k) K822734 · Gull Laboratories, Inc.
510(k) numberK822734
Submission
- Device name
- Ebv Igm Test
- Applicant
- Gull Laboratories, Inc.
Walker, MI, US - Received
- September 9, 1982
- Decision date
- December 9, 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 |
| 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 |
|---|---|---|
| K983541 | HSV 1+2 Igg Elisa TestLGC · Traditional | 02/26/1999SE |
| K971857 | Mumps Igg Elisa TestyLJY · Traditional | 11/04/1997SE |
| K962343 | Toxo Igg Elisa TestLGD · Traditional | 03/24/1997SE |
| K935730 | Ebna Igg Elisa TestLLM · Traditional | 09/19/1995SE |
| K940093 | Ebv-Ea(D) Igg Elisa TestLSE · Traditional | 09/15/1995SE |
| K941046 | VZV Igg Elisa TestLFY · Traditional | 08/24/1995SE |
| K941198 | Ebv LGG Elisa TestLSE · Traditional | 08/23/1995SE |
| K932333 | Protectoral Ultrasonic Handpiece ProcessorEFB · Traditional | 08/15/1995SE |
| K941624 | Rubella Igg Elisa TestLFX · Traditional | 08/04/1995SE |
| K922759 | HSV-2 Igm Elisa Test--ModificationLGC · Traditional | 10/05/1992SE |
Questions and answers
When was Ebv Igm Test cleared by the FDA?
Ebv Igm Test (K822734) received a 510(k) decision of Substantially Equivalent on December 9, 1982, 91 days after the submission was received.
What is the product code of K822734?
The FDA product code is JRY – Antiserum, Fluorescent, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.