Cleared Traditional

K841094 - HUMAN GROWTH HORMONE RIA KIT

K841094 is the FDA 510(k) clearance for HUMAN GROWTH HORMONE RIA KIT by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code CFL) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K841094 · Diagnostic Products Corp. · Chemistry device
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May 1984
Decision
55d
Days
Class 1
Risk

K841094 is an FDA 510(k) clearance for the HUMAN GROWTH HORMONE RIA KIT. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on May 7, 1984 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1370 - 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

Submission Details

510(k) Number K841094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1984
Decision Date May 07, 1984
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFL Radioimmunoassay, Human Growth Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1370
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 - CFL Radioimmunoassay, Human Growth Hormone

All 17
Devices cleared under the same product code (CFL) and FDA review panel - the closest regulatory comparables to K841094.
TERUMO SENSIBEAD EIA HGH KIT
K852299 · Terumo Medical Corp. · Jul 1985
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT
K851259 · Nichols Institute Diagnostics · May 1985
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT
K841088 · Nichols Institute Diagnostics · Oct 1984
TANDEM - HGH KIT
K821366 · Hybritech, Inc. · Jun 1982