Cleared Traditional

K841947 - ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT

K841947 is an FDA 510(k) clearance for ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT, manufactured by Sorin Biomedica, Fiat, USA, Inc.. The device is a Class 1 Chemistry device with product code CHP cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K841947 · Sorin Biomedica, Fiat, USA, Inc. · Chemistry device
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Jun 1984
Decision
42d
Days
Class 1
Risk

K841947 is an FDA 510(k) clearance for the ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Sorin Biomedica, Fiat, USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1984 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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 Sorin Biomedica, Fiat, USA, Inc. devices

FDA 510(k) Submission Details - K841947

510(k) Number K841947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date June 25, 1984
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

CHP Device Classification - Class 1, General Controls

Product Code CHP Radioimmunoassay, Estradiol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
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 - CHP Radioimmunoassay, Estradiol

All 40
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