Toxo Ipa Kit Ian Indirect Fluorescent
FDA 510(k) K832069 · Bionetic Laboratory Products
510(k) numberK832069
Submission
- Device name
- Toxo Ipa Kit Ian Indirect Fluorescent
- Applicant
- Bionetic Laboratory Products
Mchenry, IL, US - Received
- June 27, 1983
- Decision date
- September 26, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJK – Antisera, If, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Specialty
- Microbiology
Other 510(k)s with product code LJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974261 | Accurun 135 Toxoplasma Igg Positive ControlLJK · Traditional | Boston Biomedica, Inc. | 12/11/1997SE |
| K911771 | Ard(Tm) Antimicrobial Removal DeviceLJK · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/01/1991SE |
| K861122 | The Golden Quad Test (Toxo)LJK · Traditional | Microbiological Research Corp. | 02/02/1987SE |
| K861460 | Solid State Continuous Flow Control Model W/K101LJK · Traditional | Widran Urological Group, Ltd. | 05/02/1986SE |
| K822605 | Toxoplasma Gondii Antibody IggLJK · Traditional | Immulok, Inc. | 10/27/1982SE |
More from Immulok, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833637 | VZV Bio-Enzabead Screen KitLFY · Traditional | 02/10/1984SE |
| K832900 | Immunoenzyme Test Sys-Detect-Igm AntiGLZ · Traditional | 11/14/1983SE |
| 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 Toxo Ipa Kit Ian Indirect Fluorescent cleared by the FDA?
Toxo Ipa Kit Ian Indirect Fluorescent (K832069) received a 510(k) decision of Substantially Equivalent on September 26, 1983, 91 days after the submission was received.
What is the product code of K832069?
The FDA product code is LJK – Antisera, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.