Cleared Traditional

K771614 - AUTO. WELL TYPE GAMMA COUNTERS (FDA 510(k) Clearance)

Class I Chemistry device.

K771614 · Actus, Inc. · Chemistry device
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Apr 1978
Decision
232d
Days
Class 1
Risk

K771614 is an FDA 510(k) clearance for the AUTO. WELL TYPE GAMMA COUNTERS. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Actus, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1978 after a review of 232 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2320 - 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 Actus, Inc. devices

Submission Details

510(k) Number K771614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1977
Decision Date April 12, 1978
Days to Decision 232 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 88d · This submission: 232d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
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.