Toxoplasma Gondii Serological Reagents
FDA 510(k) K803134 · Microbiological Research Corp.
510(k) numberK803134
Submission
- Device name
- Toxoplasma Gondii Serological Reagents
- Applicant
- Microbiological Research Corp.
Mchenry, IL, US - Received
- December 12, 1980
- Decision date
- January 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GLZ – Antigens, If, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Specialty
- Microbiology
Other 510(k)s with product code GLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924882 | Toxoplasma Igm Ifa Test SystemGLZ · Traditional | Zeus Scientific, Inc. | 03/23/1993SE |
| K880007 | Toxo Igm TestGLZ · Traditional | Gull Laboratories, Inc. | 03/17/1988SE |
| K850591 | Fiax Toxo-M Antibodies Test KitGLZ · Traditional | Intl. Diagnostic Technology | 04/30/1985SE |
| K844287 | Adpifa Test for Antibodies to Toxoplasma GondiiGLZ · Traditional | Apple Diagnostic Products | 01/07/1985SE |
| K842664 | Anti-Toxoplasma Gondii KitGLZ · Traditional | Amico Lab, Inc. | 08/28/1984SE |
| K832900 | Immunoenzyme Test Sys-Detect-Igm AntiGLZ · Traditional | Bionetic Laboratory Products | 11/14/1983SE |
| K830869 | Polychaco Indirect ImmunofluorescenceGLZ · Traditional | Parasitic Disease Consultants | 08/11/1983SE |
| K811562 | Toxoplasmosis Test KitGLZ · Traditional | Immuno-Diagnostic Products, Inc. | 07/16/1981SE |
| K801720 | Toxo Bio-Bead Titration KitGLZ · Traditional | Litton Bionetics | 09/16/1980SE |
| K791618 | Torch Bio-Bead Screen KitGLZ · Traditional | Litton Bionetics | 11/13/1979SE |
More from Litton Bionetics
| 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 |
| 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 |
Questions and answers
When was Toxoplasma Gondii Serological Reagents cleared by the FDA?
Toxoplasma Gondii Serological Reagents (K803134) received a 510(k) decision of Substantially Equivalent on January 29, 1981, 48 days after the submission was received.
What is the product code of K803134?
The FDA product code is GLZ – Antigens, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.