510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893128Substantially Equivalent

Stanbio Enzymatic Urea Nitrogen Determinat #2010

Stanbio Laboratory, San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893128 is the FDA 510(k) clearance record for STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010, a class II device, cleared for Stanbio Laboratory on under FDA product code CDL (Berthelot Indophenol, Urea Nitrogen). FDA records list 47 510(k) clearances for Stanbio Laboratory, from to . As of , FDA records show no recalls naming K893128.

Clearance record

Decision date
Received
(91 days to decision)
Product code
CDL Berthelot Indophenol, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Stanbio Laboratory 2930 E. Houston St., San Antonio TX
Third party review
No

Clearances, product code CDL

Trailing 12 months

FDA records hold no clearances under product code CDL in the trailing twelve months.

FDA records show no clearances under product code CDL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CDL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260