Legionella Reagens for Direct Fluorescent Antibody
FDA 510(k) K921421 · Pro-Lab, Inc.
510(k) numberK921421
Submission
- Device name
- Legionella Reagens for Direct Fluorescent Antibody
- Applicant
- Pro-Lab, Inc.
Ontario Canada M5m 1c9, CA - Received
- March 24, 1992
- Decision date
- July 28, 1992
- 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
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|---|---|---|---|
| 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 |
| 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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| K883996 | X-Act Ldc/IndJSE · Traditional | 10/12/1988SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | 10/12/1988SE |
| K871121 | Protect T.M.JTR · Traditional | 04/14/1987SE |
| K870117 | Neisseria/Branhamella Differential TestJSX · Traditional | 03/20/1987SE |
| K861142 | Master Kit BLRP · Traditional | 07/10/1986SESD |
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Questions and answers
When was Legionella Reagens for Direct Fluorescent Antibody cleared by the FDA?
Legionella Reagens for Direct Fluorescent Antibody (K921421) received a 510(k) decision of Substantially Equivalent on July 28, 1992, 126 days after the submission was received.
What is the product code of K921421?
The FDA product code is LHL – Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, a Class II (moderate risk) device regulated under 21 CFR 866.3300.