Cleared Traditional

BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM (K944319) - FDA 510(k) Clearance

Class I Microbiology device.

K944319 · Giles Scientific, Inc. · Microbiology device
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Dec 1994
Decision
104d
Days
Class 1
Risk

K944319 is an FDA 510(k) clearance for the BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM. Classified as Reader, Zone, Automated (product code KZK), Class I - General Controls.

Submitted by Giles Scientific, Inc. (New York, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2850 - 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 Giles Scientific, Inc. devices

Submission Details

510(k) Number K944319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1994
Decision Date December 15, 1994
Days to Decision 104 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 102d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZK Reader, Zone, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2850
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.