Cleared Traditional

K791606 - GELMAN LIPOPROTEIN FRS SET. P/N 51213

K791606 is the FDA 510(k) clearance for GELMAN LIPOPROTEIN FRS SET. P/N 51213 by Gelman Sciences, Inc.. It is a Class 1 Chemistry device (product code JHO) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K791606 · Gelman Sciences, Inc. · Chemistry device
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Sep 1979
Decision
28d
Days
Class 1
Risk

K791606 is an FDA 510(k) clearance for the GELMAN LIPOPROTEIN FRS SET. P/N 51213. Classified as Electrophoretic Separation, Lipoproteins (product code JHO), Class I - General Controls.

Submitted by Gelman Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979 after a review of 28 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 Gelman Sciences, Inc. devices

Submission Details

510(k) Number K791606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1979
Decision Date September 17, 1979
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHO Electrophoretic Separation, Lipoproteins
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 - JHO Electrophoretic Separation, Lipoproteins

All 21
Devices cleared under the same product code (JHO) and FDA review panel - the closest regulatory comparables to K791606.
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE
K854057 · Beckman Instruments, Inc. · Dec 1985
TITAN GEL LIPOPROTEIN ELECTROPHORESIS
K833611 · Helena Laboratories · Mar 1984
PARAGON LIPOPROTEIN ELECTRO. REAG. KIT
K802822 · Beckman Instruments, Inc. · Dec 1980
CHOLESTEROL REAGENT SUBSTRATE SET
K781970 · Corning Medical & Scientific · Jan 1979
HDL CHOLESTEROL METHOD
K780256 · Helena Laboratories · Mar 1978