Cleared Traditional

MURINE MONOCLONAL ANTI-ADENOVIRUS IGG

K885310 · Whittaker Bioproducts, Inc. · Microbiology
Feb 1989
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K885310 is an FDA 510(k) clearance for the MURINE MONOCLONAL ANTI-ADENOVIRUS IGG, a Antisera, Fluorescent, Adenovirus 1-33 (Class I — General Controls, product code GNY), submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on February 16, 1989, 49 days after receiving the submission on December 29, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3020.

Submission Details

510(k) Number K885310 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1988
Decision Date February 16, 1989
Days to Decision 49 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GNY — Antisera, Fluorescent, Adenovirus 1-33
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3020