Cleared Traditional

ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER (K864849) - FDA 510(k) Clearance

Class I Chemistry device.

K864849 · Antek Instruments, Inc. · Chemistry device
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Aug 1987
Decision
261d
Days
Class 1
Risk

K864849 is an FDA 510(k) clearance for the ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Antek Instruments, Inc. (Houston, US). The FDA issued a Cleared decision on August 28, 1987 after a review of 261 days - an extended review 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: 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 Antek Instruments, Inc. devices

Submission Details

510(k) Number K864849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1986
Decision Date August 28, 1987
Days to Decision 261 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 88d · This submission: 261d
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 78
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