Cleared Traditional

MONEL 80&90 ULTRAVIOLET-VISIBLE SPEC. (K800523) - FDA 510(k) Clearance

Class I Chemistry device.

K800523 · Varian Assoc., Inc. · Chemistry device
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Mar 1980
Decision
14d
Days
Class 1
Risk

K800523 is an FDA 510(k) clearance for the MONEL 80&90 ULTRAVIOLET-VISIBLE SPEC.. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 20, 1980 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Varian Assoc., Inc. devices

Submission Details

510(k) Number K800523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1980
Decision Date March 20, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 35
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K800523.
AGA UV PHOTOMETER
K801499 · Syva Co. · Aug 1980
BECKMAN MODEL 42 SPECTROPHOTOMETER
K801373 · Beckman Instruments, Inc. · Jul 1980
AMES GLUCOMETER REFLECT. PHOTOMETER
K801044 · Miles Laboratories, Inc. · Jun 1980
AMES DEXTROMETER REFLECTANCE COLORIMETER
K792292 · Miles Laboratories, Inc. · Dec 1979
HEMESPEC
K782035 · Helena Laboratories · Jan 1979
UROTRON
K781632 · Boehringer Mannheim Corp. · Dec 1978