The Golden Quad Test (Toxo)
FDA 510(k) K861122 · Microbiological Research Corp.
510(k) numberK861122
Submission
- Device name
- The Golden Quad Test (Toxo)
- 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
- LJK – Antisera, If, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Specialty
- Microbiology
Other 510(k)s with product code LJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974261 | Accurun 135 Toxoplasma Igg Positive ControlLJK · Traditional | Boston Biomedica, Inc. | 12/11/1997SE |
| K911771 | Ard(Tm) Antimicrobial Removal DeviceLJK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/01/1991SE |
| K861460 | Solid State Continuous Flow Control Model W/K101LJK · Traditional | Widran Urological Group, Ltd. | 05/02/1986SE |
| K832069 | Toxo Ipa Kit Ian Indirect FluorescentLJK · Traditional | Bionetic Laboratory Products | 09/26/1983SE |
| K822605 | Toxoplasma Gondii Antibody IggLJK · Traditional | Immulok, Inc. | 10/27/1982SE |
More from Immulok, 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 |
| 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 (Toxo) cleared by the FDA?
The Golden Quad Test (Toxo) (K861122) 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 K861122?
The FDA product code is LJK – Antisera, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.