EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY— 510(k) K946353
Substantially EquivalentMrl Diagnostics
FDA 510(k) clearance K946353 for EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY, Substantially Equivalent on 1995-07-21. Applicant: Mrl Diagnostics. Device class: 1.
Clearance details
- Applicant
- Mrl Diagnostics
- 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
- Cypress, CA, 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 Mrl Diagnostics
view all- K000238 — HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
- K993754 — HSV-1 ELISA IGG, MODEL EL0910G
- K993724 — HSV-2 ELISA IGG, MODEL EL0920G
- K971006 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
- K971007 — LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
Data sourced from openFDA. This site is unofficial and independent of the FDA.