URISYS 2400 URINE TEST STRIP— 510(k) K012397

Name: FDA 510(k) clearance K012397
Creator: U.S. Food and Drug Administration
Published: 2001-09-26

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K012397 for URISYS 2400 URINE TEST STRIP, Substantially Equivalent on 2001-09-26. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2001-07-27
Decision date: 2001-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIL

view all

K193514 — AUTION MAX AX-4060 Urinalysis System2023-04-13
K183432 — cobas u 601 urinalysis test system2019-05-07
K173327 — DIP/U.S. Urine Analysis Test System2018-07-18
K180356 — inui In-Home Urine Analysis Test System2018-05-25
K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips2018-05-23

More clearances from Roche Diagnostics Corp.

view all

K130138 — SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM2013-03-15
K101365 — ELECSYS CA 19-9 CALCHECK 52010-10-05
K100853 — COBAS 8000 MODULAR SERIES ANALYZER2010-09-09
K101196 — ACCU-CHEK ULTRFLEX INFUSION SET2010-08-27
K093664 — AMPHETAMINES II ASSAY2010-07-28

Recalls naming K012397

K-number listed on FDA's recall record

Z-0099-2017 — URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.Class II·Terminated·Roche Diagnostics Operations, Inc.·20160715

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012397.

Data sourced from openFDA. This site is unofficial and independent of the FDA.