Cleared Traditional

COAT-A-COUNT MORPHINE KIT & COMPONENTS (K823680) - FDA 510(k) Clearance

Class I Chemistry device.

K823680 · Diagnostic Products Corp. · Chemistry device
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Jan 1983
Decision
29d
Days
Class 1
Risk

K823680 is an FDA 510(k) clearance for the COAT-A-COUNT MORPHINE KIT & COMPONENTS. Classified as Carbonic Anhydrase C, Antigen, Antiserum, Control (product code DDE), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Walker, US). The FDA issued a Cleared decision on January 5, 1983 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5200 - 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: 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K823680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1982
Decision Date January 05, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DDE Carbonic Anhydrase C, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5200
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.