Cleared Traditional

K772155 - ULTRACHEM TOTAL PROTEIN

K772155 is the FDA 510(k) clearance for ULTRACHEM TOTAL PROTEIN by Harleco. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K772155 · Harleco · Chemistry device
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Dec 1977
Decision
20d
Days
Class 2
Risk

K772155 is an FDA 510(k) clearance for the ULTRACHEM TOTAL PROTEIN, #64974. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on December 6, 1977 after a review of 20 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 Harleco devices

Submission Details

510(k) Number K772155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1977
Decision Date December 06, 1977
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
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.

Regulatory Peers - CEK Biuret (colorimetric), Total Protein

All 77
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K772155.
SMAC (SEQUENTIAL MULT. ANALYSIS COMP.
K792138 · Fisher Scientific Co., LLC · Nov 1979
TOTAL PROTEIN
K781774 · Gilford Diagnostics · Nov 1978
REAGENT SET, TOTAL PROTEIN
K781722 · Medical Analysis Systems, Inc. · Nov 1978
TOTAL PROTEIN SET, ITEM NO. 64010
K771926 · Harleco · Nov 1977
MULTISTAT III TOTAL PROTEIN TEST
K771476 · Instrumentation Laboratory CO · Sep 1977
AUTO TOTAL PROTEIN FOR ANALYZER
K770887 · Harleco · Jul 1977