510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013819Substantially Equivalent

Urine Collection, Preservation and Transport System

Sierra Diagnostic, LLC, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013819 is the FDA 510(k) clearance record for URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM, a class I device, cleared for Sierra Diagnostic, LLC on under FDA product code JTW (System, Transport, Aerobic). FDA records list one 510(k) clearance for Sierra Diagnostic, LLC. As of , FDA records show no recalls naming K013819.

Clearance record

Decision date
Received
(104 days to decision)
Product code
JTW System, Transport, Aerobic
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Sierra Diagnostic, LLC 1800 Massachusetts Ave. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code JTW

Trailing 12 months

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

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