Cleared Traditional

K830095 - RAPID CHEM ANALYZER II

K830095 is the FDA 510(k) clearance for RAPID CHEM ANALYZER II by Macomb Chemical Co.. It is a Class 1 Toxicology device (product code JJF) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K830095 · Macomb Chemical Co. · Toxicology device
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Jan 1983
Decision
17d
Days
Class 1
Risk

K830095 is an FDA 510(k) clearance for the RAPID CHEM ANALYZER II. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Macomb Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2170 - the FDA toxicology device 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 Macomb Chemical Co. devices

Submission Details

510(k) Number K830095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date January 28, 1983
Days to Decision 17 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 87d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
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 - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 35
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