LEGIONELLA ELISA TEST SYSTEM— 510(k) K970149
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K970149 for LEGIONELLA ELISA TEST SYSTEM, Substantially Equivalent on 1997-06-18. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- 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
- Raritan, NJ, 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
- K963318 — LEGIONELLA IGG/IGM ELISA TEST SYSTEM
- K921421 — LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
- K871328 — DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT
- K864006 — LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST
More clearances from Zeus Scientific, Inc.
view all- K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine
- K190907 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
- K191240 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
- K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
- K113397 — ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.