Cleared Traditional

K813038 - ULTRACHEM TP

K813038 is the FDA 510(k) clearance for ULTRACHEM TP by Harleco. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K813038 · Harleco · Chemistry device
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Nov 1981
Decision
13d
Days
Class 2
Risk

K813038 is an FDA 510(k) clearance for the ULTRACHEM TP, ITEM #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 November 10, 1981 after a review of 13 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 K813038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1981
Decision Date November 10, 1981
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
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 76
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K813038.
BIURET (COLORIMETRIC) TOTAL PROTEIN
K821905 · American Monitor Corp. · Jul 1982
RA-1000 SYSTEM ADD'L ANALYTES PHASE III
K820913 · Technicon Instruments Corp. · May 1982
ASTRA TOTAL PROTEIN REAGENT
K813536 · Hi Chem, Inc. · Dec 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP)
K812028 · Eastman Kodak Company · Aug 1981
TOTAL PROTEIN TEST
K811673 · King Diagnostics, Inc. · Jun 1981
IL TOTAL PROTEIN REAGENT
K802310 · Instrumentation Laboratory CO · Oct 1980