Cleared Traditional

K812768 - COAT-A-COUNT FREE & TOTAL ESTRIOL KIT

K812768 is the FDA 510(k) clearance for COAT-A-COUNT 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 105-day FDA review.

K812768 · Diagnostic Products Corp. · Chemistry device
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Jan 1982
Decision
105d
Days
Class 1
Risk

K812768 is an FDA 510(k) clearance for the COAT-A-COUNT 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 January 18, 1982 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K812768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1981
Decision Date January 18, 1982
Days to Decision 105 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
17d slower than avg
Panel avg: 88d · This submission: 105d
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 K812768.
FREE & TOTAL ESTRIOL KIT
K823202 · Diagnostic Products Corp. · Dec 1982
DSL 1400
K822314 · Diagnostic Systems Laboratories, Inc. · Sep 1982
QUANTIMUNE ESTRIOL RIA
K820728 · Bio-Rad · Apr 1982
QUANTIMUNE ESTRIOL RIA
K811709 · Bio-Rad · Jul 1981
NATAL-TEC ESTRIOL
K811371 · Armkel, LLC · May 1981
AMERLEX ESTRIOL RIA KIT
K810667 · Amersham Corp. · Mar 1981