Cleared Traditional

K944319 - BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM

K944319 is an FDA 510(k) clearance for BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM, manufactured by Giles Scientific, Inc.. The device is a Class 1 Microbiology device with product code KZK cleared through the Traditional 510(k) pathway after a 104-day FDA review.

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

FDA 510(k) Submission Details - K944319

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.

KZK Device Classification - Class 1, General Controls

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.