Polyvalent Fluorescent Antibody Reagents for Legio
FDA 510(k) K854108 · Medical Diagnostic Technologies, Inc.
510(k) numberK854108
Submission
- Device name
- Polyvalent Fluorescent Antibody Reagents for Legio
- Applicant
- Medical Diagnostic Technologies, Inc.
Augusta, GA, US - Received
- October 8, 1985
- Decision date
- November 12, 1985
- 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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| 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 |
| 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 Polyvalent Fluorescent Antibody Reagents for Legio cleared by the FDA?
Polyvalent Fluorescent Antibody Reagents for Legio (K854108) received a 510(k) decision of Substantially Equivalent on November 12, 1985, 35 days after the submission was received.
What is the product code of K854108?
The FDA product code is LHL – Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, a Class II (moderate risk) device regulated under 21 CFR 866.3300.