Cleared Traditional

GULL ELISAWARE

K912558 · Gull Laboratories, Inc. · Microbiology
Sep 1991
Decision
97d
Days
Class 1
Risk

About This 510(k) Submission

K912558 is an FDA 510(k) clearance for the GULL ELISAWARE, a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 16, 1991, 97 days after receiving the submission on June 11, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K912558 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 1991
Decision Date September 16, 1991
Days to Decision 97 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LIB — Device, General Purpose, Microbiology, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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