510(k) K822066
- Device
- LEGIONELLA PNEUMOPHILA
- Applicant
- BIODAN MEDICAL SYSTEMS, LTD.
- 510(k) number
- K822066
- Product code
- LHL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-09-21
- Date received
- 1982-07-14
- Regulation
- 866.3300
- Classification name
- Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- P.O.B. 2012 Rehovot 76120 Israel IL
FDA Registration Numbers#
- 3032705
- 2024674
- 2915274
- 2029372
- 3005360469
- 3021090658
- 2242436
- 8010383
- 3024463179
- 3033751096
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LHL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K984123 | THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E | Zeus Scientific, Inc. | 1999-01-11 |
| K970149 | LEGIONELLA ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1997-06-18 |
| K963318 | LEGIONELLA IGG/IGM ELISA TEST SYSTEM | Armkel, LLC | 1997-03-03 |
| K921421 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY | Pro-Lab, Inc. | 1992-07-28 |
| K871328 | DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT | E.I. Dupont DE Nemours & Co., Inc. | 1987-09-02 |
| K864006 | LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST | Medical Diagnostic Technologies, Inc. | 1987-04-20 |
| K854108 | POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO | Medical Diagnostic Technologies, Inc. | 1985-11-12 |
| K852237 | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT | Genetic Systems Corp. | 1985-08-22 |
| K842683 | GENETIC SYS LEGIONELLA IMMUNOFLURORES | Genetic Systems Corp. | 1984-08-02 |
| K832896 | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD | Biodan Medical Systems, Ltd. | 1983-10-14 |
| K831760 | LEGIONELLA IFA KIT I | Bionetic Laboratory Products | 1983-08-08 |
| K831026 | INDIRECT FLUORESCENT ANTIBODY REAGENTS | Zeus Technologies | 1983-06-22 |
| K830820 | LEGIONELLA DFA KIT I | Bionetic Laboratory Products | 1983-06-08 |
| K822859 | DIRECT FA CONJUGATE FOR LEGIONELLA SPP | Zeus Technologies | 1983-02-16 |
| K813339 | DIRECT FA CONJUGATE FOR LEGIONELLA SP | Springwood Microbiologicals | 1981-12-18 |
Legacy Summary#
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FDA Review#
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