Atlas FDA

DIP/U.S. Urine Analysis Test System

FDA 510(k) clearance K173327 · decided 2018-07-18

Clearance details

K-number
K173327
Device name
DIP/U.S. Urine Analysis Test System
Applicant
Healthy.Io, Ltd.
Decision
Substantially Equivalent
Date received
2017-10-20
Decision date
2018-07-18
Days to decision
271 days
Clearance type
Traditional
Product code
JIL
Device class
2
Regulation number
862.1340
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tel Aviv, IL
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
AUTION MAX AX-4060 Urinalysis System (K193514)Arkray, Inc.2023-04-13
cobas u 601 urinalysis test system (K183432)Roche Diagnostics2019-05-07
inui In-Home Urine Analysis Test System (K180356)Scanadu, Inc.2018-05-25
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips (K181024)DFI Co., Ltd.2018-05-23
DUS R-50S (Urine Chemistry system) (K171521)DFI Co., Ltd.2018-02-16
iChemVELOCITY Automated Urine Chemistry System (K171083)Iris Diagnostics, A Division of Iris International, Inc.2017-05-12
AUTION ELEVEN Semi-Automated Urinalysis System (K160062)Arkray, Inc.2016-10-07
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (K160372)Teco Diagnostics, Inc.2016-07-22
TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (K141289)Teco Diagnostics2015-07-24
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS (K131600)Teco Diagnostics2014-05-29
FORESIGHT U120 URINE ANALYZER (K120124)ACON Laboratories, Inc.2012-03-06
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 (K101673)Teco Diagnostics2011-02-04

Recalls involving this device

No recalls on record reference this clearance.