Cleared Traditional

K771777 - PONCEAU S CONCENTRATE

K771777 is an FDA 510(k) clearance for PONCEAU S CONCENTRATE, manufactured by Sigma Chemical Co.. The device is a Class 1 Chemistry device with product code HZO cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K771777 · Sigma Chemical Co. · Chemistry device
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Oct 1977
Decision
35d
Days
Class 1
Risk

K771777 is an FDA 510(k) clearance for the PONCEAU S CONCENTRATE. Classified as Stain, Ponceau (product code HZO), Class I - General Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on October 25, 1977 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.1850 - 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.

View all Sigma Chemical Co. devices

FDA 510(k) Submission Details - K771777

510(k) Number K771777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1977
Decision Date October 25, 1977
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

HZO Device Classification - Class 1, General Controls

Product Code HZO Stain, Ponceau
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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.