Immunoenzyme Test Sys-Detect-Igm Anti
FDA 510(k) K832900 · Bionetic Laboratory Products
510(k) numberK832900
Submission
- Device name
- Immunoenzyme Test Sys-Detect-Igm Anti
- Applicant
- Bionetic Laboratory Products
Mchenry, IL, US - Received
- August 29, 1983
- Decision date
- November 14, 1983
- 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 |
| 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 |
|---|---|---|
| K833637 | VZV Bio-Enzabead Screen KitLFY · Traditional | 02/10/1984SE |
| K832069 | Toxo Ipa Kit Ian Indirect FluorescentLJK · Traditional | 09/26/1983SE |
| K831760 | Legionella Ifa Kit ILHL · Traditional | 08/08/1983SE |
| K831133 | Amebiasis Bio-Enzabead Screen KitKHW · Traditional | 06/08/1983SE |
| K830820 | Legionella Dfa Kit ILHL · Traditional | 06/08/1983SE |
| K830405 | LBI-100 37DEGREES IncubatorJTQ · Traditional | 03/10/1983SE |
| K830227 | Automated Elisa Reader Lbi 300JTQ · Traditional | 03/10/1983SE |
Questions and answers
When was Immunoenzyme Test Sys-Detect-Igm Anti cleared by the FDA?
Immunoenzyme Test Sys-Detect-Igm Anti (K832900) received a 510(k) decision of Substantially Equivalent on November 14, 1983, 77 days after the submission was received.
What is the product code of K832900?
The FDA product code is GLZ – Antigens, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.