The Golden Quad Test (Ebv)
FDA 510(k) K861121 · Microbiological Research Corp.
510(k) numberK861121
Submission
- Device name
- The Golden Quad Test (Ebv)
- Applicant
- Microbiological Research Corp.
Bountiful, UT, US - Received
- March 25, 1986
- Decision date
- February 2, 1987
- 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 |
|---|---|---|
| K883011 | MRI Neo-Tryp Trypsin RiaJNO · Traditional | 04/26/1989SE |
| K861123 | The Golden Quad Test (CMV)GQI · Traditional | 02/02/1987SE |
| K861122 | The Golden Quad Test (Toxo)LJK · Traditional | 02/02/1987SE |
| K861120 | The Golden Quad Test (HSV)GQO · Traditional | 02/02/1987SE |
| K860450 | The Cmv-Igm TestLKQ · Traditional | 05/13/1986SE |
| K843138 | CMV TestLIN · Traditional | 01/29/1985SE |
| K821018 | Antihuman Igg Globulin Fitc LabeledDEW · Traditional | 04/29/1982SE |
| K821019 | Phosphate Buffered Clycerol Mounting FluLEB · Traditional | 04/26/1982SE |
| K803175 | Rubella Virus Serological ReagentsLFX · Traditional | 01/29/1981SE |
| K803134 | Toxoplasma Gondii Serological ReagentsGLZ · Traditional | 01/29/1981SE |
Questions and answers
When was The Golden Quad Test (Ebv) cleared by the FDA?
The Golden Quad Test (Ebv) (K861121) received a 510(k) decision of Substantially Equivalent on February 2, 1987, 314 days after the submission was received.
What is the product code of K861121?
The FDA product code is GNP – Antiserum, Cf, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.