Cleared Traditional

HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. (K820666) - FDA 510(k) Clearance

Class I Chemistry device.

K820666 · Immuno Nuclear Corp. · Chemistry device
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Jul 1982
Decision
124d
Days
Class 1
Risk

K820666 is an FDA 510(k) clearance for the HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.. Classified as Radioimmunoassay, C-peptides Of Proinsulin (product code JKD), Class I - General Controls.

Submitted by Immuno Nuclear Corp. (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1135 - 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 Immuno Nuclear Corp. devices

Submission Details

510(k) Number K820666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1982
Decision Date July 13, 1982
Days to Decision 124 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 88d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JKD Radioimmunoassay, C-peptides Of Proinsulin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1135
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.