Cleared Traditional

K852350 - HDL CHOLESTEROL PRETREATMENT

K852350 is an FDA 510(k) clearance for HDL CHOLESTEROL PRETREATMENT, manufactured by American Monitor Corp.. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K852350 · American Monitor Corp. · Chemistry device
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Jul 1985
Decision
38d
Days
Class 1
Risk

K852350 is an FDA 510(k) clearance for the HDL CHOLESTEROL PRETREATMENT. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by American Monitor Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 8, 1985 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 American Monitor Corp. devices

FDA 510(k) Submission Details - K852350

510(k) Number K852350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1985
Decision Date July 08, 1985
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

LBR Device Classification - Class 1, General Controls

Product Code LBR Ldl & Vldl Precipitation, Hdl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - LBR Ldl & Vldl Precipitation, Hdl

All 53
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K852350.
HDL CHOLESTEROL PRECIPITATING REAGENT
K880176 · Tech-Co, Inc. · Feb 1988
MULTICHEM HDL PRECIPITATING REAGENT #S0914
K874820 · Simmler, Inc. · Jan 1988
WORTHINGTON HDL PRECIPITATING REAGENT SET
K861926 · Cooper Biomedical, Inc. · Jun 1986
HDL CHOLESTEROL PRETREATMENT
K834251 · American Monitor Corp. · Feb 1984
HDL EZ-TAB
K833160 · Preventive Diagnostics Corp. · Feb 1984
HDL EX-SEP PRECIPITATING REAGENT
K833431 · Preventive Diagnostics Corp. · Jan 1984