EBNA ACIF KIT— 510(k) K840417
Substantially EquivalentLitton Bionetics
FDA 510(k) clearance K840417 for EBNA ACIF KIT, Substantially Equivalent on 1984-12-27. Applicant: Litton Bionetics. Device class: 1.
Clearance details
- Applicant
- Litton Bionetics
- 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
- Charleston, SC, 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 Litton Bionetics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.