Cleared Traditional

K831623 - DIA STRIPS SYSTEM

K831623 is an FDA 510(k) clearance for DIA STRIPS SYSTEM, manufactured by California Immuno Diagnostic, Inc.. The device is a Class 1 Chemistry device with product code CDM cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K831623 · California Immuno Diagnostic, Inc. · Chemistry device
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Jul 1983
Decision
69d
Days
Class 1
Risk

K831623 is an FDA 510(k) clearance for the DIA STRIPS SYSTEM. Classified as Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (product code CDM), Class I - General Controls.

Submitted by California Immuno Diagnostic, Inc. (Walker, US). The FDA issued a Cleared decision on July 28, 1983 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1785 - 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 California Immuno Diagnostic, Inc. devices

FDA 510(k) Submission Details - K831623

510(k) Number K831623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1983
Decision Date July 28, 1983
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

CDM Device Classification - Class 1, General Controls

Product Code CDM Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1785
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 - CDM Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)

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