EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590— 510(k) K883871

Name: FDA 510(k) clearance K883871
Creator: U.S. Food and Drug Administration
Published: 1989-07-14

Substantially Equivalent

Clinical Sciences, Inc.

FDA 510(k) clearance K883871 for EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590, Substantially Equivalent on 1989-07-14. Applicant: Clinical Sciences, Inc.. Device class: 1.

Clearance details

Applicant: Clinical Sciences, Inc.
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1988-09-13
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whippany, NJ, 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 Clinical Sciences, Inc.

view all

K900688 — VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT1990-05-15
K883870 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #45901989-07-14
K891990 — RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #46001989-06-15
K883600 — EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #45501989-05-11
K883601 — EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #55501989-05-11

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