Cleared Traditional

K944417 - ZEUA MYCOPLASMA (FDA 510(k) Clearance)

Class I Microbiology device.

K944417 · Zeus Scientific, Inc. · Microbiology device
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Aug 1995
Decision
329d
Days
Class 1
Risk

K944417 is an FDA 510(k) clearance for the ZEUA MYCOPLASMA. Classified as Antisera, Fluorescent, All, Mycoplasma Spp. (product code GRZ), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on August 1, 1995 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3375 - 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 Zeus Scientific, Inc. devices

Submission Details

510(k) Number K944417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1994
Decision Date August 01, 1995
Days to Decision 329 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
227d slower than avg
Panel avg: 102d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GRZ Antisera, Fluorescent, All, Mycoplasma Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3375
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.