510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023992Substantially Equivalent

Wiener Lab Colinesterasa Aa

Wiener Laboratories Saic, Rosario, Santa Fe, AR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023992 is the FDA 510(k) clearance record for WIENER LAB COLINESTERASA AA, a class I device, cleared for Wiener Laboratories Saic on under FDA product code DIH (Colorimetry, Cholinesterase). FDA records list 24 510(k) clearances for Wiener Laboratories Saic, from to . As of , FDA records show no recalls naming K023992.

Clearance record

Decision date
Received
(72 days to decision)
Product code
DIH Colorimetry, Cholinesterase
Regulation
21 CFR 862.3240
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Wiener Laboratories Saic 2571 Maipu, Rosario, Santa Fe, AR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DIH

Trailing 12 months

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

FDA records show no clearances under product code DIH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIH, 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