510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023744Substantially Equivalent

Wiener Lab. Ck-Mb Ds UV Unitest, Model 28 X 2.5 Ml Cat. Nr. 1271354

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

K023744 is the FDA 510(k) clearance record for WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354, a class II device, cleared for Wiener Laboratories Saic on under FDA product code JHW (U.V. Method, Cpk Isoenzymes). FDA records list 24 510(k) clearances for Wiener Laboratories Saic, from to . As of , FDA records show no recalls naming K023744.

Clearance record

Decision date
Received
(57 days to decision)
Product code
JHW U.V. Method, Cpk Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Wiener Laboratories Saic 2944 Riobamba, Rosario, Santa Fe, AR
510(k) summary
Statement
Third party review
No

Clearances, product code JHW

Trailing 12 months

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

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