Cleared Traditional

K760480 - REAGENT

K760480 is the FDA 510(k) clearance for REAGENT by Simmler & Son, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K760480 · Simmler & Son, Inc. · Chemistry device
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Oct 1976
Decision
73d
Days
Class 2
Risk

K760480 is an FDA 510(k) clearance for the REAGENT, TOTAL PROTEIN DETERMINATION. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Simmler & Son, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 29, 1976 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - 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 Simmler & Son, Inc. devices

Submission Details

510(k) Number K760480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1976
Decision Date October 29, 1976
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEK Biuret (colorimetric), Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.