Cleared Traditional

K771256 - GAS CHROMATOGRAPH (FDA 510(k) Clearance)

K771256 · Varian Assoc., Inc. · Toxicology device
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Oct 1977
Decision
91d
Days
-
Risk

K771256 is an FDA 510(k) clearance for the GAS CHROMATOGRAPH.

Submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 7, 1977 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Varian Assoc., Inc. devices

Submission Details

510(k) Number K771256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1977
Decision Date October 07, 1977
Days to Decision 91 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 87d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -