Cleared Traditional

K932122 - BIOMIC VIDEO PLATE READER

K932122 is an FDA 510(k) clearance for BIOMIC VIDEO PLATE READER, 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 302-day FDA review.

K932122 · Giles Scientific, Inc. · Microbiology device
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Mar 1994
Decision
302d
Days
Class 1
Risk

K932122 is an FDA 510(k) clearance for the BIOMIC VIDEO PLATE READER. 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 March 1, 1994 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K932122

510(k) Number K932122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1993
Decision Date March 01, 1994
Days to Decision 302 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
200d slower than avg
Panel avg: 102d · This submission: 302d
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.