GENETIC SYS LEGIONELLA IMMUNOFLURORES— 510(k) K842683
Substantially EquivalentGenetic Systems Corp.
FDA 510(k) clearance K842683 for GENETIC SYS LEGIONELLA IMMUNOFLURORES, Substantially Equivalent on 1984-08-02. Applicant: Genetic Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Genetic Systems Corp.
- Product code
- Code LHL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3300
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code LHL
view all- K984123 — THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E
- K970149 — LEGIONELLA ELISA TEST SYSTEM
- K963318 — LEGIONELLA IGG/IGM ELISA TEST SYSTEM
- K921421 — LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
- K871328 — DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT
More clearances from Genetic Systems Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.