Cleared Traditional

K945489 - LYFO(TM) DIFFERENTIAL DISK (FDA 510(k) Clearance)

Class I Microbiology device.

K945489 · Microbiologics, Inc. · Microbiology device
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May 1995
Decision
184d
Days
Class 1
Risk

K945489 is an FDA 510(k) clearance for the LYFO(TM) DIFFERENTIAL DISK. Classified as Kit, Anaerobic Identification (product code JSP), Class I - General Controls.

Submitted by Microbiologics, Inc. (St. Cloud, US). The FDA issued a Cleared decision on May 11, 1995 after a review of 184 days - an extended review cycle.

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 Microbiologics, Inc. devices

Submission Details

510(k) Number K945489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1994
Decision Date May 11, 1995
Days to Decision 184 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
82d slower than avg
Panel avg: 102d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSP Kit, Anaerobic Identification
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.