Cleared Traditional

K823202 - FREE & TOTAL ESTRIOL KIT

K823202 is the FDA 510(k) clearance for FREE & TOTAL ESTRIOL KIT by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code CGI) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

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
Combination Product No
PCCP Authorized No
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 21
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K823202.
IMMPULSE FREE ESTRIOL ASSAY REAGENTS
K860900 · Sclavo, Inc. · Apr 1986
TDX TOTAL ESTRIOL
K844511 · Abbott Laboratories · Jan 1985
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED
K844408 · Amersham Corp. · Dec 1984
DSL 1400
K822314 · Diagnostic Systems Laboratories, Inc. · Sep 1982
QUANTIMUNE ESTRIOL RIA
K820728 · Bio-Rad · Apr 1982
COAT-A-COUNT FREE & TOTAL ESTRIOL KIT
K812768 · Diagnostic Products Corp. · Jan 1982