Legionella Elisa Test System
FDA 510(k) K970149 · Zeus Scientific, Inc.
510(k) numberK970149
Submission
- Device name
- Legionella Elisa Test System
- Applicant
- Zeus Scientific, Inc.
Raritan, NJ, US - Received
- January 15, 1997
- Decision date
- June 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K831760 | Legionella Ifa Kit ILHL · Traditional | Bionetic Laboratory Products | 08/08/1983SE |
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Questions and answers
When was Legionella Elisa Test System cleared by the FDA?
Legionella Elisa Test System (K970149) received a 510(k) decision of Substantially Equivalent on June 18, 1997, 154 days after the submission was received.
What is the product code of K970149?
The FDA product code is LHL – Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, a Class II (moderate risk) device regulated under 21 CFR 866.3300.