Cleared Traditional

K912858 - LONDON DIAGNOSTICS LUMATAG HGH CHEM IMM...

K912858 is the FDA 510(k) clearance for LONDON DIAGNOSTICS LUMATAG HGH CHEM IMM... by London Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CFL) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K912858 · London Diagnostics, Inc. · Chemistry device
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Jul 1991
Decision
32d
Days
Class 1
Risk

K912858 is an FDA 510(k) clearance for the LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by London Diagnostics, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on July 30, 1991 after a review of 32 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 London Diagnostics, Inc. devices

Submission Details

510(k) Number K912858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1991
Decision Date July 30, 1991
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 22
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K905757 · Tosoh Medics, Inc. · Jan 1991
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K896808 · Nichols Institute Diagnostics · Jan 1990
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K896643 · Medix Biotech, Inc. · Dec 1989