Toxoplasma Gondii Antibody Igg
FDA 510(k) K822605 · Immulok, Inc.
510(k) numberK822605
Submission
- Device name
- Toxoplasma Gondii Antibody Igg
- Applicant
- Immulok, Inc.
Mchenry, IL, US - Received
- August 27, 1982
- Decision date
- October 27, 1982
- 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 |
| K832069 | Toxo Ipa Kit Ian Indirect FluorescentLJK · Traditional | Bionetic Laboratory Products | 09/26/1983SE |
More from Bionetic Laboratory Products
| 510(k) | Device | Decision |
|---|---|---|
| K830971 | Herpes Simplex Virus Typing ReagentsGQL · Traditional | 06/30/1983SE |
| K830342 | Culuture Set Chlamydia Isolation andLKI · Traditional | 05/04/1983SE |
| K830250 | CVT Viral TransportsJTW · Traditional | 02/28/1983SE |
| K823304 | Riaset Prolactin Ria KitCFT · Traditional | 12/22/1982SE |
| K822785 | Fluoroset Immunofluorescent AntibodyGQL · Traditional | 11/29/1982SE |
| K823055 | Flouroset Immunofluorescent AntibodyDHN · Traditional | 11/05/1982SE |
| K822606 | Cytomegalovirus Antobody IggLIN · Traditional | 11/01/1982SE |
| K822607 | Antinuclear Antobody Cell SubstrateDHN · Traditional | 09/17/1982SE |
| K821567 | Immulok CulturesetGQL · Traditional | 06/25/1982SE |
| K821411 | Histoset Immunoperofidase TissueGQL · Traditional | 06/25/1982SE |
Questions and answers
When was Toxoplasma Gondii Antibody Igg cleared by the FDA?
Toxoplasma Gondii Antibody Igg (K822605) received a 510(k) decision of Substantially Equivalent on October 27, 1982, 61 days after the submission was received.
What is the product code of K822605?
The FDA product code is LJK – Antisera, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.