Genetic Sys Legionella Immunoflurores
FDA 510(k) K842683 · Genetic Systems Corp.
510(k) numberK842683
Submission
- Device name
- Genetic Sys Legionella Immunoflurores
- Applicant
- Genetic Systems Corp.
Mchenry, IL, US - Received
- July 10, 1984
- Decision date
- August 2, 1984
- 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 |
| K832896 | Legionella Indirect Fluorescent AntibodLHL · Traditional | Biodan Medical Systems, Ltd. | 10/14/1983SE |
| K831760 | Legionella Ifa Kit ILHL · Traditional | Bionetic Laboratory Products | 08/08/1983SE |
More from Bionetic Laboratory Products
| 510(k) | Device | Decision |
|---|---|---|
| K891767 | Genetic Systems Microplate ReaderJJQ · Traditional | 07/25/1989SE |
| K891768 | Genetic Systems Microplate WasherJTC · Traditional | 05/01/1989SE |
| K891766 | Genetic Systems Microplate Strip WasherJTC · Traditional | 05/01/1989SE |
| K891765 | Genetic Systems Pipettor/DilutorJTC · Traditional | 05/01/1989SE |
| K890768 | Pneumocystis Carinii Immunofluorescence Test KitLYF · Traditional | 03/21/1989SE |
| K873564 | Genetic Systems RSV Reagent Control SlidesLKT · Traditional | 11/20/1987SE |
| K873542 | Microplate Auto-Washer (Motorized Stage)JTC · Traditional | 09/23/1987SE |
| K870176 | Genetic Systems RSV Immunofluorescence Test KitLKT · Traditional | 07/16/1987SE |
| K870879 | Alanine Transaminase (Alt) Test KitCKA · Traditional | 03/19/1987SE |
| K863566 | GSC 1000JJQ · Traditional | 10/16/1986SE |
Questions and answers
When was Genetic Sys Legionella Immunoflurores cleared by the FDA?
Genetic Sys Legionella Immunoflurores (K842683) received a 510(k) decision of Substantially Equivalent on August 2, 1984, 23 days after the submission was received.
What is the product code of K842683?
The FDA product code is LHL – Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, a Class II (moderate risk) device regulated under 21 CFR 866.3300.