Cleared Traditional

K843914 - COBAS FLUORESCENCE POLARIZATION MODULE

K843914 is an FDA 510(k) clearance for COBAS FLUORESCENCE POLARIZATION MODULE, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Toxicology device with product code JJG cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K843914 · Roche Diagnostic Systems, Inc. · Toxicology device
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Nov 1984
Decision
54d
Days
Class 1
Risk

K843914 is an FDA 510(k) clearance for the COBAS FLUORESCENCE POLARIZATION MODULE. Classified as Analyzer, Chemistry, Centrifugal, For Clinical Use (product code JJG), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Walker, US). The FDA issued a Cleared decision on November 27, 1984 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2140 - the FDA toxicology 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K843914

510(k) Number K843914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1984
Decision Date November 27, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 87d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

JJG Device Classification - Class 1, General Controls

Product Code JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2140
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 - JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

All 22
Devices cleared under the same product code (JJG) and FDA review panel - the closest regulatory comparables to K843914.
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