Legionella Ifa Kit I
FDA 510(k) K831760 · Bionetic Laboratory Products
510(k) numberK831760
Submission
- Device name
- Legionella Ifa Kit I
- Applicant
- Bionetic Laboratory Products
Mchenry, IL, US - Received
- June 1, 1983
- Decision date
- August 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LHL – Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3300
- Specialty
- Microbiology
Other 510(k)s with product code LHL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984123 | The Aptus (Automated) Application of the Legionella Igg/A/M (Elisa) Test System. an…LHL · Traditional | Zeus Scientific, Inc. | 01/11/1999SE |
| K970149 | Legionella Elisa Test SystemLHL · Traditional | Zeus Scientific, Inc. | 06/18/1997SE |
| K963318 | Legionella Igg/Igm Elisa Test SystemLHL · Traditional | Armkel, LLC | 03/03/1997SE |
| K921421 | Legionella Reagens for Direct Fluorescent AntibodyLHL · Traditional | Pro-Lab, Inc. | 07/28/1992SE |
| K871328 | Du Pont Legionella Urinary Antigen - Ria KitLHL · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/02/1987SE |
| K864006 | Legionella Pneumophila Ser. 1 Antigen Latex TestLHL · Traditional | Medical Diagnostic Technologies, Inc. | 04/20/1987SE |
| K854108 | Polyvalent Fluorescent Antibody Reagents for LegioLHL · Traditional | Medical Diagnostic Technologies, Inc. | 11/12/1985SE |
| K852237 | Legionella Immunofluorescent Antibody Test KitLHL · Traditional | Genetic Systems Corp. | 08/22/1985SE |
| K842683 | Genetic Sys Legionella ImmunofluroresLHL · Traditional | Genetic Systems Corp. | 08/02/1984SE |
| K832896 | Legionella Indirect Fluorescent AntibodLHL · Traditional | Biodan Medical Systems, Ltd. | 10/14/1983SE |
More from Biodan Medical Systems, Ltd.
| 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 |
| K832069 | Toxo Ipa Kit Ian Indirect FluorescentLJK · Traditional | 09/26/1983SE |
| 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 Legionella Ifa Kit I cleared by the FDA?
Legionella Ifa Kit I (K831760) received a 510(k) decision of Substantially Equivalent on August 8, 1983, 68 days after the submission was received.
What is the product code of K831760?
The FDA product code is LHL – Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, a Class II (moderate risk) device regulated under 21 CFR 866.3300.