Ebv-Vca Antibody (Igg)
FDA 510(k) K884591 · Hillcrest Biologicals
510(k) numberK884591
Submission
- Device name
- Ebv-Vca Antibody (Igg)
- Applicant
- Hillcrest Biologicals
Cypress, CA, US - Received
- November 3, 1988
- Decision date
- January 24, 1989
- 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 |
| 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 |
|---|---|---|
| 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 |
| K884829 | Ebv Early Antigen (R+D)JRY · Traditional | 04/12/1989SE |
| K883767 | Lyme Disease Ifa (Igm)LSR · Traditional | 03/15/1989SE |
| K883487 | Lyme Disease Ifa (Igg)LSR · Traditional | 12/13/1988SE |
| K875170 | Ebna AntibodyLLM · Traditional | 05/23/1988SE |
Questions and answers
When was Ebv-Vca Antibody (Igg) cleared by the FDA?
Ebv-Vca Antibody (Igg) (K884591) received a 510(k) decision of Substantially Equivalent on January 24, 1989, 82 days after the submission was received.
What is the product code of K884591?
The FDA product code is GNP – Antiserum, Cf, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.