Cleared Traditional

EBV EARLY ANTIGEN (R+D)

K884829 · Hillcrest Biologicals · Microbiology
Apr 1989
Decision
145d
Days
Class 1
Risk

About This 510(k) Submission

K884829 is an FDA 510(k) clearance for the EBV EARLY ANTIGEN (R+D), a Antiserum, Fluorescent, Epstein-barr Virus (Class I — General Controls, product code JRY), submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on April 12, 1989, 145 days after receiving the submission on November 18, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K884829 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1988
Decision Date April 12, 1989
Days to Decision 145 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JRY — Antiserum, Fluorescent, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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