Cleared Traditional

K800921 - NORDICLAB TESTOSTERONE RIA TEST

K800921 is an FDA 510(k) clearance for NORDICLAB TESTOSTERONE RIA TEST, manufactured by Nordiclab Intl.. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K800921 · Nordiclab Intl. · Chemistry device
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May 1980
Decision
23d
Days
Class 1
Risk

K800921 is an FDA 510(k) clearance for the NORDICLAB TESTOSTERONE RIA TEST. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Nordiclab Intl. (Walker, US). The FDA issued a Cleared decision on May 14, 1980 after a review of 23 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 Nordiclab Intl. devices

FDA 510(k) Submission Details - K800921

510(k) Number K800921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1980
Decision Date May 14, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
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 K800921.
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