Toxo Bio-Bead Titration Kit
FDA 510(k) K801720 · Litton Bionetics
510(k) numberK801720
Submission
- Device name
- Toxo Bio-Bead Titration Kit
- Applicant
- Litton Bionetics
Mchenry, IL, US - Received
- July 23, 1980
- Decision date
- September 16, 1980
- 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 |
| K811562 | Toxoplasmosis Test KitGLZ · Traditional | Immuno-Diagnostic Products, Inc. | 07/16/1981SE |
| K803134 | Toxoplasma Gondii Serological ReagentsGLZ · Traditional | Microbiological Research Corp. | 01/29/1981SE |
| K791618 | Torch Bio-Bead Screen KitGLZ · Traditional | Litton Bionetics | 11/13/1979SE |
More from Litton Bionetics
| 510(k) | Device | Decision |
|---|---|---|
| K840417 | Ebna Acif KitLLM · Traditional | 12/27/1984SE |
| K834443 | Rotavirus Bio-Enzabead Screen KitLIQ · Traditional | 03/16/1984SE |
| K831343 | CMV RQ Bio-Enzabead KitLFZ · Traditional | 08/08/1983SE |
| K822985 | Ebv-M KitJRY · Traditional | 12/03/1982SE |
| K821804 | Rubella RQ Bio-Enzabead KitLFX · Traditional | 09/14/1982SE |
| K801722 | CMV Bio-Bead Titration KitGQH · Traditional | 09/16/1980SE |
| K801721 | HSV Bio-Bead Titration KitGQN · Traditional | 09/16/1980SE |
| K800789 | Rubella Bio-Bead Titration KitGOL · Traditional | 06/30/1980SE |
| K791618 | Torch Bio-Bead Screen KitGLZ · Traditional | 11/13/1979SE |
| K791614 | HSV Bio-Bead Screen KitGQN · Traditional | 11/13/1979SE |
Questions and answers
When was Toxo Bio-Bead Titration Kit cleared by the FDA?
Toxo Bio-Bead Titration Kit (K801720) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 55 days after the submission was received.
What is the product code of K801720?
The FDA product code is GLZ – Antigens, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.