Cleared Traditional

K842049 - FLUOROSKAN

K842049 is an FDA 510(k) clearance for FLUOROSKAN, manufactured by Flow Laboratories, Inc.. The device is a Class 1 Immunology device with product code JZT cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K842049 · Flow Laboratories, Inc. · Immunology device
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Dec 1984
Decision
195d
Days
Class 1
Risk

K842049 is an FDA 510(k) clearance for the FLUOROSKAN. Classified as Fluorometer (product code JZT), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mclean, US). The FDA issued a Cleared decision on December 3, 1984 after a review of 195 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Flow Laboratories, Inc. devices

FDA 510(k) Submission Details - K842049

510(k) Number K842049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1984
Decision Date December 03, 1984
Days to Decision 195 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
90d slower than avg
Panel avg: 105d · This submission: 195d
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 7
Devices cleared under the same product code (JZT) and FDA review panel - the closest regulatory comparables to K842049.
QLIA IMMUNOCHEMISTRY SYSTEM
K883349 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
THE FIAX 5000 FLUOROMETER
K863434 · Whittaker Bioproducts, Inc. · Oct 1986
PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM
K862674 · Hybritech, Inc. · Aug 1986
FIAX 100 FLUOROMETER
K843356 · Intl. Diagnostic Technology · Sep 1984
FLUROMETER, DADE
K782150 · Dade, Baxter Travenol Diagnostics, Inc. · Feb 1979
VIEWER, FLUOROMETIC, MODEL 721
K770662 · Corning Medical & Scientific · Apr 1977