Cleared Traditional

DETECTADOT SYSTEM 2000 CMV IGG TEST

K875159 · Gull Laboratories, Inc. · Microbiology
May 1988
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K875159 is an FDA 510(k) clearance for the DETECTADOT SYSTEM 2000 CMV IGG TEST, a Antiserum, Cf, Cytomegalovirus (Class II — Special Controls, product code GQI), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 6, 1988, 142 days after receiving the submission on December 16, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K875159 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1987
Decision Date May 06, 1988
Days to Decision 142 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQI — Antiserum, Cf, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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