Cleared Traditional

INDIRECT FLUORESCENT ANTIBODY MYCO (K840012) - FDA 510(k) Clearance

Class I Microbiology device.

K840012 · Zeus Technologies · Microbiology device
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Feb 1984
Decision
54d
Days
Class 1
Risk

K840012 is an FDA 510(k) clearance for the INDIRECT FLUORESCENT ANTIBODY MYCO. Classified as Antisera, Fluorescent, All, Mycoplasma Spp. (product code GRZ), Class I - General Controls.

Submitted by Zeus Technologies (Mchenry, US). The FDA issued a Cleared decision on February 27, 1984 after a review of 54 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zeus Technologies devices

Submission Details

510(k) Number K840012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1984
Decision Date February 27, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 102d · This submission: 54d
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.