Cleared Traditional

K893128 - STANBIO ENZYMATIC UREA NITROGEN DETERMI...

K893128 is the FDA 510(k) clearance for STANBIO ENZYMATIC UREA NITROGEN DETERMI... by Stanbio Laboratory. It is a Class 2 Chemistry device (product code CDL) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K893128 · Stanbio Laboratory · Chemistry device
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Jul 1989
Decision
91d
Days
Class 2
Risk

K893128 is an FDA 510(k) clearance for the STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010. Classified as Berthelot Indophenol, Urea Nitrogen (product code CDL), Class II - Special Controls.

Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on July 25, 1989 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Stanbio Laboratory devices

Submission Details

510(k) Number K893128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1989
Decision Date July 25, 1989
Days to Decision 91 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
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDL Berthelot Indophenol, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDL Berthelot Indophenol, Urea Nitrogen

Devices cleared under the same product code (CDL) and FDA review panel - the closest regulatory comparables to K893128.
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K792417 · Volu Sol Medical Industries · Dec 1979