510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023889Substantially Equivalent

Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254

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

K023889 is the FDA 510(k) clearance record for WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254, a class I device, cleared for Wiener Laboratories Saic on under FDA product code MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi). FDA records list 24 510(k) clearances for Wiener Laboratories Saic, from to . As of , FDA records show one recall naming K023889.

Clearance record

Decision date
Received
(447 days to decision)
Product code
MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
Regulation
21 CFR 866.3870
Device class
Class I
Review panel
Microbiology
Applicant
Wiener Laboratories Saic 2944 Riobamba, Rosario, Santa Fe, AR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MIU

Trailing 12 months

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

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