Cleared Traditional

K833009 - OMNI-FAL I & II

K833009 is an FDA 510(k) clearance for OMNI-FAL I & II, manufactured by American Monitor Corp.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K833009 · American Monitor Corp. · Chemistry device
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Jan 1984
Decision
129d
Days
Class 1
Risk

K833009 is an FDA 510(k) clearance for the OMNI-FAL I & II. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 American Monitor Corp. devices

FDA 510(k) Submission Details - K833009

510(k) Number K833009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1983
Decision Date January 13, 1984
Days to Decision 129 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
41d slower than avg
Panel avg: 88d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 594
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K833009.
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