Cleared Traditional

K802661 - LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT

K802661 is an FDA 510(k) clearance for LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT, manufactured by Damon Corp.. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K802661 · Damon Corp. · Chemistry device
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Dec 1980
Decision
43d
Days
Class 1
Risk

K802661 is an FDA 510(k) clearance for the LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Damon Corp. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1980 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1680 - 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 Damon Corp. devices

FDA 510(k) Submission Details - K802661

510(k) Number K802661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1980
Decision Date December 10, 1980
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

CDZ Device Classification - Class 1, General Controls

Product Code CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1680
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 - CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 70
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K802661.
LEECO TESTO-QUANT DIAG. KIT
K813059 · Leeco Diagnostics, Inc. · Nov 1981
DIRECT TESTOSTERONE RIA
K811536 · Immuchem Corp. · Jun 1981
LEECO TESTO-QUANT DIAGNOSTIC KIT
K803001 · Leeco Diagnostics, Inc. · Jan 1981
TESTOSTERONE KIT
K801666 · Immuchem Corp. · Aug 1980
TESTOK-125
K800776 · Sorin Biomedica, Fiat, USA, Inc. · Apr 1980
TESTOSTERONE RIA KIT (125I)
K772191 · Diagnostic Products Corp. · Jan 1978