Eia for Igg Antibody to Ebv Vca in Human Serum
FDA 510(k) K901156 · Granbio, Inc.
510(k) numberK901156
Submission
- Device name
- Eia for Igg Antibody to Ebv Vca in Human Serum
- Applicant
- Granbio, Inc.
Temecula, CA, US - Received
- March 13, 1990
- Decision date
- September 12, 1990
- 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 |
| 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 |
| K871373 | Ebv-Check(Tm) Test Kit (Igg)GNP · Traditional | Diagnostic Technology, Inc. | 06/25/1987SE |
More from Diagnostic Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951822 | Ebna Enzyme Immunoassay KitLLM · Traditional | 02/15/1996SE |
| K934774 | UnknownLSE · Traditional | 04/20/1994SE |
| K901840 | (Eia) for Igm Antibody to Ebv Vca in Human SerumLJN · Traditional | 09/12/1990SE |
| K881617 | Indirect Immunofluorescent Antibody AssayLSE · Traditional | 06/07/1988SE |
| K871298 | Ebna Acif Assay KitLLM · Traditional | 06/25/1987SE |
| K864604 | Ebv Vca Igm Antibody Assay KitLJN · Traditional | 02/02/1987SE |
| K864347 | Indirect Immunofluorescent Antibody Assay/ Ebv-VcaGNP · Traditional | 02/02/1987SE |
Questions and answers
When was Eia for Igg Antibody to Ebv Vca in Human Serum cleared by the FDA?
Eia for Igg Antibody to Ebv Vca in Human Serum (K901156) received a 510(k) decision of Substantially Equivalent on September 12, 1990, 183 days after the submission was received.
What is the product code of K901156?
The FDA product code is GNP – Antiserum, Cf, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.