EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550— 510(k) K883601
Substantially EquivalentClinical Sciences, Inc.
FDA 510(k) clearance K883601 for EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550, Substantially Equivalent on 1989-05-11. Applicant: Clinical Sciences, Inc.. Device class: 1.
Clearance details
- Applicant
- Clinical Sciences, 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
- Whippany, 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 Clinical Sciences, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.