Fiax Toxo-M Antibodies Test Kit
FDA 510(k) K850591 · Intl. Diagnostic Technology
510(k) numberK850591
Submission
- Device name
- Fiax Toxo-M Antibodies Test Kit
- Applicant
- Intl. Diagnostic Technology
San Jose, CA, US - Received
- February 14, 1985
- Decision date
- April 30, 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 |
| 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 |
| 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 |
|---|---|---|
| K843570 | Fiax Haptoglobin Test KitDAB · Traditional | 10/05/1984SE |
| K843621 | Fiax 420 DilutorJQW · Traditional | 09/28/1984SE |
| K843356 | Fiax 100 FluorometerJZT · Traditional | 09/17/1984SE |
| K842749 | Fiax Total Ige Test KitDGP · Traditional | 08/28/1984SE |
| K842071 | Fiax Transferrin Test KitDDI · Traditional | 07/11/1984SE |
| K841174 | Rubella Antibody FluoroimmunoassayGOL · Traditional | 06/07/1984SE |
| K840867 | ALPHA-1-ANTITRYPSIN, Fitc, AntigenDEI · Traditional | 05/11/1984SE |
| K834140 | Antinuclear Antibody Immunological SysKTL · Traditional | 01/20/1984SE |
| K833984 | Antinuclear Antibody ImmunologicalKTL · Traditional | 01/04/1984SE |
| K832821 | Fiax Igg TestDFI · Traditional | 10/14/1983SE |
Questions and answers
When was Fiax Toxo-M Antibodies Test Kit cleared by the FDA?
Fiax Toxo-M Antibodies Test Kit (K850591) received a 510(k) decision of Substantially Equivalent on April 30, 1985, 75 days after the submission was received.
What is the product code of K850591?
The FDA product code is GLZ – Antigens, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.