Cleared Traditional

COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS

K912489 · Immuno Concepts, Inc. · Microbiology
Jul 1991
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K912489 is an FDA 510(k) clearance for the COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on July 24, 1991, 50 days after receiving the submission on June 4, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K912489 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 1991
Decision Date July 24, 1991
Days to Decision 50 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LSE — Epstein-barr Virus, Other
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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