Cleared Traditional

K863434 - THE FIAX 5000 FLUOROMETER

K863434 is an FDA 510(k) clearance for THE FIAX 5000 FLUOROMETER, manufactured by Whittaker Bioproducts, Inc.. The device is a Class 1 Immunology device with product code JZT cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K863434 · Whittaker Bioproducts, Inc. · Immunology device
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Oct 1986
Decision
55d
Days
Class 1
Risk

K863434 is an FDA 510(k) clearance for the THE FIAX 5000 FLUOROMETER. Classified as Fluorometer (product code JZT), Class I - General Controls.

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on October 29, 1986 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4520 - the FDA immunology 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.

FDA 510(k) Submission Details - K863434

510(k) Number K863434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1986
Decision Date October 29, 1986
Days to Decision 55 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 105d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

JZT Device Classification - Class 1, General Controls

Product Code JZT Fluorometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4520
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.

Regulatory Peers - JZT Fluorometer

All 13
Devices cleared under the same product code (JZT) and FDA review panel - the closest regulatory comparables to K863434.
QLIA IMMUNOCHEMISTRY SYSTEM
K883349 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
STAT-20 FLUOROMETER
K882677 · Weaver Medical · Jul 1988
FLUORESCENCE CONCENTRATION ANALYZER (FCA)
K864699 · Pandex Laboratories, Inc. · Dec 1986
PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM
K862674 · Hybritech, Inc. · Aug 1986
SMS, SCREEN MACHINE SYSTEM
K852240 · Pandex Laboratories, Inc. · Jun 1985
FLUOROSKAN
K842049 · Flow Laboratories, Inc. · Dec 1984
K863434 · THE FIAX 5000 FLUOROMETER
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