CMV EARLY ANTIGEN TEST— 510(k) K942171

Substantially Equivalent

Neogenex

FDA 510(k) clearance K942171 for CMV EARLY ANTIGEN TEST, Substantially Equivalent on 1994-06-30. Applicant: Neogenex. Device class: 2.

Clearance details

Applicant: Neogenex
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1994-05-05
Decision date: 1994-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Everett, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQI

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K883102 — VIRGO (R) CMV-IGG ELISA1989-02-08
K875159 — DETECTADOT SYSTEM 2000 CMV IGG TEST1988-05-06
K863488 — ENZYGNOST ANTI-CMV IGG TEST1987-07-20

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K943885 — PRIMARY RABBIT KIDNEY CELL CULTURE1994-11-28
K943886 — BGM CELL CULTURE1994-11-28

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