Cleared Traditional

FREE & TOTAL ESTRIOL KIT (K823202) - FDA 510(k) Clearance

Class I Chemistry device.

K823202 · Diagnostic Products Corp. · Chemistry device
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Dec 1982
Decision
50d
Days
Class 1
Risk

K823202 is an FDA 510(k) clearance for the FREE & TOTAL ESTRIOL KIT. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on December 15, 1982 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1265 - 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 K823202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1982
Decision Date December 15, 1982
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGI Radioimmunoassay, Estriol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1265
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 - CGI Radioimmunoassay, Estriol

All 41
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K823202.
COAT-A-COUNT FREE ESTRIOL
K932989 · Diagnostic Products Corp. · Dec 1994
TDX TOTAL ESTRIOL
K844511 · Abbott Laboratories · Jan 1985
ARIA II 125- I-ESTRIOL SYSTEM
K801735 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1980
RIA-120 AND ESTRIOL REAGENT SYSTEM
K770465 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1977