Cleared Traditional

K944417 - ZEUA MYCOPLASMA

K944417 is an FDA 510(k) clearance for ZEUA MYCOPLASMA, manufactured by Zeus Scientific, Inc.. The device is a Class 1 Microbiology device with product code GRZ cleared through the Traditional 510(k) pathway after a 329-day FDA review.

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

FDA 510(k) Submission Details - K944417

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 102d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

GRZ Device Classification - Class 1, General Controls

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.