Cleared Traditional

K771073 - GAS CHROMA. ANALYSIS SYS., SERIES 37111 (FDA 510(k) Clearance)

K771073 · Varian Assoc., Inc. · Chemistry device
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Oct 1977
Decision
133d
Days
-
Risk

K771073 is an FDA 510(k) clearance for the GAS CHROMA. ANALYSIS SYS., SERIES 37111.

Submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 25, 1977 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel. 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.

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Submission Details

510(k) Number K771073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1977
Decision Date October 25, 1977
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 88d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -