EBV/VCA-CHECK(TM) ANTIGEN SLIDES— 510(k) K863408

Name: FDA 510(k) clearance K863408
Creator: U.S. Food and Drug Administration
Published: 1986-11-28

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K863408 for EBV/VCA-CHECK(TM) ANTIGEN SLIDES, Substantially Equivalent on 1986-11-28. Applicant: Diagnostic Technology, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code GNP
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1986-09-03
Decision date: 1986-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GNP

view all

K020706 — EBV-VCA IGG ELISA TEST, MODEL EBG-1002002-06-13
K020707 — EBV-EBNA IGG ELISA KIT, MODEL EBG-1002002-06-13
K020717 — EBV V VCA IGM ELISA KIT MODEL# EBM-2002002-06-13
K981829 — IS EBV-EBNA-1 IGG ELISA TEST SYSTEM1999-02-16
K981831 — IS EBV-EA-D IGG ELISA TEST SYSTEM1999-02-16

More clearances from Diagnostic Technology, Inc.

view all

K896378 — LYME-CHECK(TM) TEST KIT1991-11-05
K903612 — EBV/EA-CHECK TM TEST KIT1990-10-16
K890639 — RESUBMITTED EBV/IGM-CHECK TEST KIT1989-06-20
K890819 — HSV-CHECK(TM) TEST KIT1989-06-20
K891542 — EBNA-CHECK(TM) TEST KIT1989-06-20

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