Cleared Traditional

RUBEOLA TEST

K884004 · Gull Laboratories, Inc. · Microbiology
Dec 1988
Decision
75d
Days
Class 1
Risk

About This 510(k) Submission

K884004 is an FDA 510(k) clearance for the RUBEOLA TEST, a Antiserum, Fluorescent, Rubeola (Class I — General Controls, product code GRE), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 5, 1988, 75 days after receiving the submission on September 21, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3520.

Submission Details

510(k) Number K884004 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1988
Decision Date December 05, 1988
Days to Decision 75 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GRE — Antiserum, Fluorescent, Rubeola
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3520