EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST— 510(k) K882440
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K882440 for EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST, Substantially Equivalent on 1988-12-15. Applicant: Zeus Scientific, Inc.. Device class: 1.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code LLM
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
Recent devices under product code LLM
view all- K233605 — ADVIA Centaur EBV-EBNA IgG
- K040120 — DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
- K984133 — THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
- K973941 — IMMUNOWELL EBNA IGG TEST
- K980598 — EBNA-1 IGM ELISA TEST SYSTEM
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.