Cleared Traditional

K946373 - MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K946373 · Zeus Scientific, Inc. · Microbiology device
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Feb 1996
Decision
518d
Days
Class 1
Risk

K946373 is an FDA 510(k) clearance for the MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM. 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 February 7, 1996 after a review of 518 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Zeus Scientific, Inc. devices

Submission Details

510(k) Number K946373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1994
Decision Date February 07, 1996
Days to Decision 518 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
416d slower than avg
Panel avg: 102d · This submission: 518d
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.