Ebv(Epstein-Barr Virus) Test Kit
FDA 510(k) K854207 · Immuno-Diagnostic Products, Inc.
510(k) numberK854207
Submission
- Device name
- Ebv(Epstein-Barr Virus) Test Kit
- Applicant
- Immuno-Diagnostic Products, Inc.
North Salt Lake, UT, US - Received
- October 16, 1985
- Decision date
- April 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNP – Antiserum, Cf, Epstein-Barr Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
Other 510(k)s with product code GNP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020717 | Ebv V Vca Igm Elisa Kit Model# EBM-200GNP · Traditional | Pan Bio Pty. , Ltd. | 06/13/2002SE |
| K020707 | Ebv-Ebna Igg Elisa Kit, Model EBG-100GNP · Traditional | Pan Bio Pty. , Ltd. | 06/13/2002SE |
| K020706 | Ebv-Vca Igg Elisa Test, Model EBG-100GNP · Traditional | Pan Bio Pty. , Ltd. | 06/13/2002SE |
| K981831 | Is Ebv-Ea-D Igg Elisa Test SystemGNP · Traditional | Diamedix Corp. | 02/16/1999SE |
| K981829 | Is EBV-EBNA-1 Igg Elisa Test SystemGNP · Traditional | Diamedix Corp. | 02/16/1999SE |
| K901156 | Eia for Igg Antibody to Ebv Vca in Human SerumGNP · Traditional | Granbio, Inc. | 09/12/1990SE |
| K883670 | Serological Test Kit for Igg Anti. Epstein-Barr ViGNP · Traditional | Electro-Nucleonics, Inc. | 04/28/1989SE |
| K884591 | Ebv-Vca Antibody (Igg)GNP · Traditional | Hillcrest Biologicals | 01/24/1989SE |
| K880885 | Ebv-Vca Igg Antibody Test System (Enzyme)GNP · Traditional | Immuno Concepts, Inc. | 08/30/1988SE |
| K880883 | Ebv-Vca Igg Antibody Test System (Fluorescent)GNP · Traditional | Immuno Concepts, Inc. | 08/30/1988SE |
More from Immuno Concepts, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K811021 | HerpesGQN · Traditional | 11/05/1981SE |
| K811562 | Toxoplasmosis Test KitGLZ · Traditional | 07/16/1981SE |
| K811022 | Ana Test KitDHN · Traditional | 04/23/1981SE |
| K801963 | CMV Test KitGQH · Traditional | 10/23/1980SE |
| K801959 | Fta-Abs TestJWL · Traditional | 10/23/1980SE |
| K801961 | Rf-Ii Test KitDHR · Traditional | 10/10/1980SE |
| K801960 | Anti-Ds/N-Dna Test KitDBL · Traditional | 10/10/1980SE |
Questions and answers
When was Ebv(Epstein-Barr Virus) Test Kit cleared by the FDA?
Ebv(Epstein-Barr Virus) Test Kit (K854207) received a 510(k) decision of Substantially Equivalent on April 24, 1986, 190 days after the submission was received.
What is the product code of K854207?
The FDA product code is GNP – Antiserum, Cf, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.