MERIDIAN EBV-EA TEST KIT— 510(k) K925688

Name: FDA 510(k) clearance K925688
Creator: U.S. Food and Drug Administration
Published: 1993-10-12

Substantially Equivalent

Fuller Laboratories, Inc.

FDA 510(k) clearance K925688 for MERIDIAN EBV-EA TEST KIT, Substantially Equivalent on 1993-10-12. Applicant: Fuller Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Fuller Laboratories, Inc.
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1992-11-12
Decision date: 1993-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LSE

view all

K260221 — Elecsys EBV EBNA IgG2026-10-02
K260232 — Elecsys EBV VCA IgG2026-10-02
K233606 — ADVIA Centaur EBV-VCA IgM2024-08-07
K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set2017-01-05
K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set2017-01-04

More clearances from Fuller Laboratories, Inc.

view all

K931557 — FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST1994-03-11
K925689 — MERIDIAN EBV-IGG TEST KIT1993-10-12
K925690 — MERIDIAN EBNA TEST KIT1993-10-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.