The Golden Quad Test (CMV)
FDA 510(k) K861123 · Microbiological Research Corp.
510(k) numberK861123
Submission
- Device name
- The Golden Quad Test (CMV)
- 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
- GQI – Antiserum, Cf, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
Other 510(k)s with product code GQI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952254 | Enzyme Linked Immunoabsorbent Assay, CytomegalovirusGQI · Traditional | Pyramid Biological Corp. | 11/16/1995SE |
| K951800 | CMV Igg Human Serum ControlsGQI · Traditional | Pyramid Biological Corp. | 11/16/1995SE |
| K942171 | CMV Early Antigen TestGQI · Traditional | Neogenex | 06/30/1994SE |
| K883102 | Virgo (R) Cmv-Igg ElisaGQI · Traditional | Electro-Nucleonics, Inc. | 02/08/1989SE |
| K875159 | Detectadot System 2000 CMV Igg TestGQI · Traditional | Gull Laboratories, Inc. | 05/06/1988SE |
| K863488 | Enzygnost Anti-Cmv Igg TestGQI · Traditional | Behring Diagnostics, Inc. | 07/20/1987SE |
| K864420 | CMV MicroassayGQI · Traditional | Diamedix Corp. | 02/02/1987SE |
| K862705 | Cytomegalovirus Igg Eia Test KitGQI · Traditional | Labsystems, Inc. | 10/01/1986SE |
| K853989 | Cor Dot CMVGQI · Traditional | Cordis Corp. | 06/13/1986SE |
| K860493 | Cytotech CMV Igg EiaGQI · Traditional | Cytotech, Inc. | 05/20/1986SE |
More from Cytotech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883011 | MRI Neo-Tryp Trypsin RiaJNO · Traditional | 04/26/1989SE |
| K861122 | The Golden Quad Test (Toxo)LJK · Traditional | 02/02/1987SE |
| K861121 | The Golden Quad Test (Ebv)GNP · 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 (CMV) cleared by the FDA?
The Golden Quad Test (CMV) (K861123) 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 K861123?
The FDA product code is GQI – Antiserum, Cf, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.