Cleared Traditional

K833160 - HDL EZ-TAB

K833160 is an FDA 510(k) clearance for HDL EZ-TAB, manufactured by Preventive Diagnostics Corp.. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K833160 · Preventive Diagnostics Corp. · Chemistry device
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Feb 1984
Decision
146d
Days
Class 1
Risk

K833160 is an FDA 510(k) clearance for the HDL EZ-TAB. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Preventive Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1984 after a review of 146 days - within the typical 510(k) review window.

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: 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 Preventive Diagnostics Corp. devices

FDA 510(k) Submission Details - K833160

510(k) Number K833160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1983
Decision Date February 09, 1984
Days to Decision 146 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
58d slower than avg
Panel avg: 88d · This submission: 146d
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 54
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K833160.
WORTHINGTON HDL PRECIPITATING REAGENT SET
K861926 · Cooper Biomedical, Inc. · Jun 1986
HDL CHOLESTEROL PRETREATMENT
K852350 · American Monitor Corp. · Jul 1985
HDL CHOLESTEROL PRETREATMENT
K834251 · American Monitor Corp. · Feb 1984
HDL EX-SEP PRECIPITATING REAGENT
K833431 · Preventive Diagnostics Corp. · Jan 1984
RAICHEM HDL-CHOLESTEROL REAGENT
K830207 · Reagents Applications, Inc. · Mar 1983
HDL PRECIPITANT REAGENT SET
K821203 · Omega Medical Electronics · Jul 1982