510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070062Substantially Equivalent

Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General Use

Diesse Diagnostica Senese S.P.A, Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070062 is the FDA 510(k) clearance record for COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE, a class I device, cleared for Diesse Diagnostica Senese S.P.A. on under FDA product code LIO (Device, Specimen Collection). FDA records list 2 510(k) clearances for Diesse Diagnostica Senese S.P.A., from to . As of , FDA records show no recalls naming K070062.

Clearance record

Decision date
Received
(206 days to decision)
Product code
LIO Device, Specimen Collection
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Diesse Diagnostica Senese S.P.A. 1690 W 38 Pl., Hialeah FL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code LIO

Trailing 12 months

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

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