Toxogen
FDA 510(k) K913467 · Biokit USA, Inc.
510(k) numberK913467
Submission
- Device name
- Toxogen
- Applicant
- Biokit USA, Inc.
Barcelona, ES - Received
- August 5, 1991
- Decision date
- January 11, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LLA – Direct Agglutination Test, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Specialty
- Microbiology
Other 510(k)s with product code LLA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890048 | Quik-Dot ToxoplasmosisLLA · Traditional | Ampcor, Inc. | 06/09/1989SE |
| K850768 | Toxoscan Card Test KitLLA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/20/1985SE |
| K831930 | Toxo-Screen Da TestLLA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/26/1983SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K910541 | Biokit RPRGMQ · Traditional | 10/18/1991SE |
| K904310 | Rheumagen RF T-ControlDHR · Traditional | 05/31/1991SE |
| K910539 | Rheumajet RFDHR · Traditional | 04/05/1991SE |
| K910686 | Rheumajet CRPDCN · Traditional | 03/19/1991SE |
| K904311 | Rheumagen Aso T-ControlGTQ · Traditional | 01/25/1991SE |
| K904312 | Rheumagen CRP T-ControlDCK · Traditional | 10/01/1990SE |
| K896433 | Modified RubagenLQN · Traditional | 11/29/1989SE |
| K896272 | Quantex CRP Plus (Latex, Buffer, Standard, ControlDCN · Traditional | 11/08/1989SE |
| K896271 | Quantex RF Plus (Latex, Buffer Standard, Control)DHR · Traditional | 11/08/1989SE |
| K894486 | Quantex Aso Plus (Latex,Buffer Standard,Control)GTQ · Traditional | 10/24/1989SE |
Questions and answers
When was Toxogen cleared by the FDA?
Toxogen (K913467) received a 510(k) decision of Substantially Equivalent on January 11, 1993, 525 days after the submission was received.
What is the product code of K913467?
The FDA product code is LLA – Direct Agglutination Test, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.