Cleared Traditional

K903647 - MODULE 486 VARIABLE WAVELENGTH TUNABLE ...

K903647 is an FDA 510(k) clearance for MODULE 486 VARIABLE WAVELENGTH TUNABLE ..., manufactured by Millipore Corp.. The device is a Class 1 Chemistry device with product code LDM cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K903647 · Millipore Corp. · Chemistry device
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Sep 1990
Decision
33d
Days
Class 1
Risk

K903647 is an FDA 510(k) clearance for the MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE. Classified as Instrumentation, High Pressure Liquid Chromatography (product code LDM), Class I - General Controls.

Submitted by Millipore Corp. (Milford, US). The FDA issued a Cleared decision on September 11, 1990 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2260 - 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 Millipore Corp. devices

FDA 510(k) Submission Details - K903647

510(k) Number K903647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1990
Decision Date September 11, 1990
Days to Decision 33 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
55d faster than avg
Panel avg: 88d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

LDM Device Classification - Class 1, General Controls

Product Code LDM Instrumentation, High Pressure Liquid Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2260
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 - LDM Instrumentation, High Pressure Liquid Chromatography

All 17
Devices cleared under the same product code (LDM) and FDA review panel - the closest regulatory comparables to K903647.
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
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MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
K884886 · The Perkin-Elmer Corp. · Feb 1989
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM
K872582 · Millipore Corp. · Jul 1987
WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM
K870949 · Millipore Corp. · Apr 1987