Cleared Traditional

K760348 - REAGENT SYSTEM, SIGMA PROCEDURE NO. 270 (FDA 510(k) Clearance)

Class I Chemistry device.

K760348 · Sigma Chemical Co. · Chemistry device
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Oct 1976
Decision
86d
Days
Class 1
Risk

K760348 is an FDA 510(k) clearance for the REAGENT SYSTEM, SIGMA PROCEDURE NO. 270. Classified as Zimmerman/norymberski, 17-ketogenic Steroids (product code CCZ), Class I - General Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1976 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1385 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K760348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1976
Decision Date October 27, 1976
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCZ Zimmerman/norymberski, 17-ketogenic Steroids
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1385
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.