Cleared Traditional

K843122 - RESOLVE-CSF

K843122 is an FDA 510(k) clearance for RESOLVE-CSF, manufactured by Isolab, Inc.. The device is a Class 1 Chemistry device with product code DFI cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K843122 · Isolab, Inc. · Chemistry device
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Nov 1984
Decision
114d
Days
Class 1
Risk

K843122 is an FDA 510(k) clearance for the RESOLVE-CSF. Classified as Total Spinal-fluid, Antigen, Antiserum, Control (product code DFI), Class I - General Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on November 30, 1984 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5860 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Isolab, Inc. devices

FDA 510(k) Submission Details - K843122

510(k) Number K843122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1984
Decision Date November 30, 1984
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 88d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

DFI Device Classification - Class 1, General Controls

Product Code DFI Total Spinal-fluid, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5860
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.