Legionella Pneumophila Ser. 1 Antigen Latex Test
FDA 510(k) K864006 · Medical Diagnostic Technologies, Inc.
510(k) numberK864006
Submission
- Device name
- Legionella Pneumophila Ser. 1 Antigen Latex Test
- Applicant
- Medical Diagnostic Technologies, Inc.
Augusta, GA, US - Received
- October 15, 1986
- Decision date
- April 20, 1987
- 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
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| K871328 | Du Pont Legionella Urinary Antigen - Ria KitLHL · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/02/1987SE |
| 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 |
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| 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 Pneumophila Ser. 1 Antigen Latex Test cleared by the FDA?
Legionella Pneumophila Ser. 1 Antigen Latex Test (K864006) received a 510(k) decision of Substantially Equivalent on April 20, 1987, 187 days after the submission was received.
What is the product code of K864006?
The FDA product code is LHL – Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, a Class II (moderate risk) device regulated under 21 CFR 866.3300.