Cleared Traditional

K832115 - ATAC 3000

K832115 is the FDA 510(k) clearance for ATAC 3000 by Turpen Laboratory Systems, Inc.. It is a Class 1 Chemistry device (product code JJE) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K832115 · Turpen Laboratory Systems, Inc. · Chemistry device
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Jan 1984
Decision
194d
Days
Class 1
Risk

K832115 is an FDA 510(k) clearance for the ATAC 3000. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Turpen Laboratory Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 194 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 Turpen Laboratory Systems, Inc. devices

Submission Details

510(k) Number K832115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1983
Decision Date January 10, 1984
Days to Decision 194 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 88d · This submission: 194d
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 143
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