EBNA-1 IGM ELISA TEST SYSTEM— 510(k) K982348
Substantially EquivalentColumbia Bioscience, Inc.
FDA 510(k) clearance K982348 for EBNA-1 IGM ELISA TEST SYSTEM, Substantially Equivalent on 1998-11-25. Applicant: Columbia Bioscience, Inc.. Device class: 1.
Clearance details
- Applicant
- Columbia Bioscience, Inc.
- Product code
- Code LSE
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
Recent devices under product code LSE
view all- K233606 — ADVIA Centaur EBV-VCA IgM
- K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
- K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
- K091260 — SERAQUEST EBV EA-D IGG TEST
- K073382 — PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
More clearances from Columbia Bioscience, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.