Cleared Traditional

K912558 - GULL ELISAWARE

K912558 is the FDA 510(k) clearance for GULL ELISAWARE by Gull Laboratories, Inc.. It is a Class 1 Microbiology device (product code LIB) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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

K912558 is an FDA 510(k) clearance for the GULL ELISAWARE. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 16, 1991 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gull Laboratories, Inc. devices

Submission Details

510(k) Number K912558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 102d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LIB Device, General Purpose, Microbiology, Diagnostic

All 13
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K912558.
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