Toxoplasmosis Test Kit
FDA 510(k) K811562 · Immuno-Diagnostic Products, Inc.
510(k) numberK811562
Submission
- Device name
- Toxoplasmosis Test Kit
- Applicant
- Immuno-Diagnostic Products, Inc.
Mchenry, IL, US - Received
- June 3, 1981
- Decision date
- July 16, 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 |
| K803134 | Toxoplasma Gondii Serological ReagentsGLZ · Traditional | Microbiological Research Corp. | 01/29/1981SE |
| 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 |
|---|---|---|
| K854207 | Ebv(Epstein-Barr Virus) Test KitGNP · Traditional | 04/24/1986SE |
| K811021 | HerpesGQN · Traditional | 11/05/1981SE |
| K811022 | Ana Test KitDHN · Traditional | 04/23/1981SE |
| K801963 | CMV Test KitGQH · Traditional | 10/23/1980SE |
| K801959 | Fta-Abs TestJWL · Traditional | 10/23/1980SE |
| K801961 | Rf-Ii Test KitDHR · Traditional | 10/10/1980SE |
| K801960 | Anti-Ds/N-Dna Test KitDBL · Traditional | 10/10/1980SE |
Questions and answers
When was Toxoplasmosis Test Kit cleared by the FDA?
Toxoplasmosis Test Kit (K811562) received a 510(k) decision of Substantially Equivalent on July 16, 1981, 43 days after the submission was received.
What is the product code of K811562?
The FDA product code is GLZ – Antigens, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.