Toxoplasma Igm Ifa Test System
FDA 510(k) K924882 · Zeus Scientific, Inc.
510(k) numberK924882
Submission
- Device name
- Toxoplasma Igm Ifa Test System
- Applicant
- Zeus Scientific, Inc.
Raritan, NJ, US - Received
- September 28, 1992
- Decision date
- March 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Toxoplasma Igm Ifa Test System cleared by the FDA?
Toxoplasma Igm Ifa Test System (K924882) received a 510(k) decision of Substantially Equivalent on March 23, 1993, 176 days after the submission was received.
What is the product code of K924882?
The FDA product code is GLZ – Antigens, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.