Cleared Traditional

K800572 - KDA MICRO CHEMICAL ANALYZER

K800572 is an FDA 510(k) clearance for KDA MICRO CHEMICAL ANALYZER, manufactured by American Monitor Corp.. The device is a Class 1 Chemistry device with product code JJE cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K800572 · American Monitor Corp. · Chemistry device
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Apr 1980
Decision
19d
Days
Class 1
Risk

K800572 is an FDA 510(k) clearance for the KDA MICRO CHEMICAL ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1980 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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.

FDA 510(k) Submission Details - K800572

510(k) Number K800572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1980
Decision Date April 02, 1980
Days to Decision 19 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
70d faster than avg
Panel avg: 89d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 207
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K800572 · KDA MICRO CHEMICAL ANALYZER
Download PDF American Monitor Corp.