Adpifa Test for Antibodies to Toxoplasma Gondii
FDA 510(k) K844287 · Apple Diagnostic Products
510(k) numberK844287
Submission
- Device name
- Adpifa Test for Antibodies to Toxoplasma Gondii
- Applicant
- Apple Diagnostic Products
Pipersille, PA, US - Received
- November 5, 1984
- Decision date
- January 7, 1985
- 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 |
| 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 |
| 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 |
|---|---|---|
| K843745 | Adp Ana ApplezymeLJM · Traditional | 10/25/1984SE |
| K843120 | Applelisa Chlamydia Trachomatis AntiLJC · Traditional | 09/12/1984SE |
| K842707 | Adp Ndna Ifa TestKTL · Traditional | 08/21/1984SE |
| K842183 | Adp Ana Ifa TestDHN · Traditional | 06/22/1984SE |
| K834241 | Ana ApplelisaDHN · Traditional | 04/04/1984SE |
| K834242 | Adp Ifa Test for Chlamydiae TrachomatisLJP · Traditional | 03/02/1984SE |
Questions and answers
When was Adpifa Test for Antibodies to Toxoplasma Gondii cleared by the FDA?
Adpifa Test for Antibodies to Toxoplasma Gondii (K844287) received a 510(k) decision of Substantially Equivalent on January 7, 1985, 63 days after the submission was received.
What is the product code of K844287?
The FDA product code is GLZ – Antigens, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.