Cleared Traditional

K813043 - ULTRACHEM CREA ITEM #64972

K813043 is the FDA 510(k) clearance for ULTRACHEM CREA ITEM #64972 by Harleco. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K813043 · Harleco · Chemistry device
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Nov 1981
Decision
13d
Days
Class 2
Risk

K813043 is an FDA 510(k) clearance for the ULTRACHEM CREA ITEM #64972. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), 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 862.1225 - 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 K813043 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 CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 111
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K813043.
COBAS REAGENT FOR CREATININE
K823573 · Hoffmann-La Roche, Inc. · Jan 1983
LIQUIZYME CREATININE REAGENT SET
K813560 · Amresco, Inc. · Jan 1982
SERALYZER CREATININE REAGENT STRIPS
K820075 · Miles Laboratories, Inc. · Jan 1982
GILCHEM CREATININE REAGENT
K812109 · Gilford Diagnostics · Aug 1981
CREATININE REAGENT
K811659 · Gilford Diagnostics · Jun 1981
CREATININE TEST
K811664 · King Diagnostics, Inc. · Jun 1981