LHL — Reagents, Antibody, Legionella, Direct & Indirect Fluorescent Class II
FDA product code LHL covers "Reagents, Antibody, Legionella, Direct & Indirect Fluorescent", a Class II medical device regulated under 21 CFR 866.3300. Submissions are reviewed by the Microbiology panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LHL
- Device Class
- Class II
- Regulation Number
- 866.3300
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K984123 | zeus scientific | THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. | January 11, 1999 |
| K970149 | zeus scientific | LEGIONELLA ELISA TEST SYSTEM | June 18, 1997 |
| K963318 | armkel | LEGIONELLA IGG/IGM ELISA TEST SYSTEM | March 3, 1997 |
| K921421 | pro-lab | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY | July 28, 1992 |
| K871328 | e.i. dupont de nemours and co | DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT | September 2, 1987 |
| K864006 | medical diagnostic technologies | LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST | April 20, 1987 |
| K854108 | medical diagnostic technologies | POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO | November 12, 1985 |
| K852237 | genetic systems | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT | August 22, 1985 |
| K842683 | genetic systems | GENETIC SYS LEGIONELLA IMMUNOFLURORES | August 2, 1984 |
| K832896 | biodan medical systems | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD | October 14, 1983 |
| K831760 | bionetic laboratory products | LEGIONELLA IFA KIT I | August 8, 1983 |
| K831026 | zeus technologies | INDIRECT FLUORESCENT ANTIBODY REAGENTS | June 22, 1983 |
| K830820 | bionetic laboratory products | LEGIONELLA DFA KIT I | June 8, 1983 |
| K822859 | zeus technologies | DIRECT FA CONJUGATE FOR LEGIONELLA SPP | February 16, 1983 |
| K822066 | biodan medical systems | LEGIONELLA PNEUMOPHILA | September 21, 1982 |
| K813339 | springwood microbiologicals | DIRECT FA CONJUGATE FOR LEGIONELLA SP | December 18, 1981 |
| K812007 | centers for disease control and prevention | LEGIONELLA INDIRECT FLUOR. ANTIBODY | September 8, 1981 |
| K812006 | centers for disease control and prevention | LEGIONELLA DIRECT FLUORESCENT ANTIBODY | September 8, 1981 |