Cleared Traditional

K823202 - FREE & TOTAL ESTRIOL KIT

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

K823202 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K823202

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.

CGI Device Classification - Class 1, General Controls

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 31
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K823202.
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED
K844408 · Amersham Corp. · Dec 1984
ENDAB ESTRIOL UNCONJUGATED
K840902 · Immunotech Corp. · Apr 1984
RIANEN ESTRIOL RADIOIMMUNOASSAY KIT
K840301 · New England Nuclear · Mar 1984
MICROMEDIC ESTRIOL RIA KIT
K822578 · Micromedic Systems · Oct 1982
DSL 1400
K822314 · Diagnostic Systems Laboratories, Inc. · Sep 1982
AUTOPAK ESTRIOL TEST DELIVERY SYSTEM
K821678 · Micromedic Systems · Jun 1982