Cleared Traditional

K884378 - DACOS OR DACOS XL CLINICAL CHEMISTRY AN...

K884378 is the FDA 510(k) clearance for DACOS OR DACOS XL CLINICAL CHEMISTRY AN... by Coulter Corp.. It is a Class 1 Chemistry device (product code JJE) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K884378 · Coulter Corp. · Chemistry device
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Feb 1989
Decision
132d
Days
Class 1
Risk

K884378 is an FDA 510(k) clearance for the DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Coulter Corp. (Hialeah, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 132 days - within the typical 510(k) review window.

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: 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 Coulter Corp. devices

Submission Details

510(k) Number K884378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1988
Decision Date February 27, 1989
Days to Decision 132 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
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 140
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