Cleared Traditional

K811864 - SIGMA PROCEDURE 265-UV

K811864 is the FDA 510(k) clearance for SIGMA PROCEDURE 265-UV by Sigma Chemical Co.. It is a Class 1 Chemistry device (product code CED) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K811864 · Sigma Chemical Co. · Chemistry device
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Jul 1981
Decision
30d
Days
Class 1
Risk

K811864 is an FDA 510(k) clearance for the SIGMA PROCEDURE 265-UV. Classified as 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase (product code CED), Class I - General Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on July 31, 1981 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1520 - 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

Submission Details

510(k) Number K811864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date July 31, 1981
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CED 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1520
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.

Regulatory Peers - CED 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase

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