Cleared Traditional

K893128 - STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010

K893128 is an FDA 510(k) clearance for STANBIO ENZYMATIC UREA NITROGEN DETERMI..., manufactured by Stanbio Laboratory. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K893128

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.

CDL Device Classification - Class 2, Special Controls

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

All 12
Devices cleared under the same product code (CDL) and FDA review panel - the closest regulatory comparables to K893128.
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K864742 · Tech-Co, Inc. · Jan 1987
UREA NITROGEN TEST
K863889 · U. S. Diagnostics, Inc. · Nov 1986
UREAFAST
K863076 · J. D. Assoc. · Sep 1986
BUN (ENZYMATIC BERTHELOT) REAGENT SET
K860154 · Sterling Diagnostics, Inc. · Feb 1986