510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K801727Substantially Equivalent

Data-Zyme Urea Nitrogen, Colorimetric

Data Medical Associates, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801727 is the FDA 510(k) clearance record for DATA-ZYME UREA NITROGEN, COLORIMETRIC, a class II device, cleared for Data Medical Associates, Inc. on under FDA product code CDL (Berthelot Indophenol, Urea Nitrogen). FDA records list 111 510(k) clearances for Data Medical Associates, Inc., from to . As of , FDA records show no recalls naming K801727.

Clearance record

Decision date
Received
(47 days to decision)
Product code
CDL Berthelot Indophenol, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Data Medical Associates, Inc. 803 N. Front St. Suite 3, Mchenry IL
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