Cleared Traditional

K851332 - BLHI LUTEINIZING HORMONE

K851332 is the FDA 510(k) clearance for BLHI LUTEINIZING HORMONE by Euro-Diagnostics BV. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K851332 · Euro-Diagnostics BV · Chemistry device
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Jul 1985
Decision
96d
Days
Class 1
Risk

K851332 is an FDA 510(k) clearance for the BLHI LUTEINIZING HORMONE. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Euro-Diagnostics BV (Old Greenwich, US). The FDA issued a Cleared decision on July 9, 1985 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Euro-Diagnostics BV devices

Submission Details

510(k) Number K851332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1985
Decision Date July 09, 1985
Days to Decision 96 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 88d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
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 - CEP Radioimmunoassay, Luteinizing Hormone

All 71
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K851332.
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AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
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LH RIA
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