Panels › Microbiology › Product code LHL · Class 2
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Regulation 866.3300
0510(k)s in 12 months (18 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in LHL
| Company | 510(k)s | Recalls |
|---|---|---|
| Biodan Medical Systems, Ltd. | 2 | 0 |
| Bionetic Laboratory Products | 2 | 0 |
| Centers for Disease Control and Prevention | 2 | 0 |
| Focus Diagnostics Inc | 0 | 2 |
| Genetic Systems Corp. | 2 | 0 |
| Medical Diagnostic Technologies, Inc. | 2 | 0 |
| Zeus Scientific, Inc. | 2 | 0 |
| Zeus Technologies | 2 | 0 |
| Armkel, LLC | 1 | 0 |
| Diamedix Corporation | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 1999 | K984123 | THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E Zeus Scientific, Inc. | LHL |
| Jun 18, 1997 | K970149 | LEGIONELLA ELISA TEST SYSTEM Zeus Scientific, Inc. | LHL |
| Mar 3, 1997 | K963318 | LEGIONELLA IGG/IGM ELISA TEST SYSTEM Armkel, LLC | LHL |
| Jul 28, 1992 | K921421 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY Pro-Lab, Inc., CA | LHL |
| Sep 2, 1987 | K871328 | DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT E.I. Dupont DE Nemours & Co., Inc. | LHL |
| Apr 20, 1987 | K864006 | LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST Medical Diagnostic Technologies, Inc. | LHL |
| Nov 12, 1985 | K854108 | POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO Medical Diagnostic Technologies, Inc. | LHL |
| Aug 22, 1985 | K852237 | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT Genetic Systems Corp. | LHL |
| Aug 2, 1984 | K842683 | GENETIC SYS LEGIONELLA IMMUNOFLURORES Genetic Systems Corp. | LHL |
| Oct 14, 1983 | K832896 | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD Biodan Medical Systems, Ltd. | LHL |
| Aug 8, 1983 | K831760 | LEGIONELLA IFA KIT I Bionetic Laboratory Products | LHL |
| Jun 22, 1983 | K831026 | INDIRECT FLUORESCENT ANTIBODY REAGENTS Zeus Technologies | LHL |
| Jun 8, 1983 | K830820 | LEGIONELLA DFA KIT I Bionetic Laboratory Products | LHL |
| Feb 16, 1983 | K822859 | DIRECT FA CONJUGATE FOR LEGIONELLA SPP Zeus Technologies | LHL |
| Sep 21, 1982 | K822066 | LEGIONELLA PNEUMOPHILA Biodan Medical Systems, Ltd., IL | LHL |
| Dec 18, 1981 | K813339 | DIRECT FA CONJUGATE FOR LEGIONELLA SP Springwood Microbiologicals | LHL |
| Sep 8, 1981 | K812007 | LEGIONELLA INDIRECT FLUOR. ANTIBODY Centers for Disease Control and Prevention | LHL |
| Sep 8, 1981 | K812006 | LEGIONELLA DIRECT FLUORESCENT ANTIBODY Centers for Disease Control and Prevention | LHL |
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