Irispec Urine Chemistry Control Part a and B

FDA 510(k) K945913 · International Remote Imaging Systems

Substantially Equivalent

510(k) numberK945913

Submission

Device name
Irispec Urine Chemistry Control Part a and B
Applicant
International Remote Imaging Systems
Chartsworth, CA, US
Received
December 2, 1994
Decision date
April 5, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JJW – Urinalysis Controls (Assayed And Unassayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

Other 510(k)s with product code JJW

510(k)DeviceApplicantDecision
K170091UA-Cellular CompleteJJW · Traditional Streck02/09/2017SE
K142262Aution Check PlusJJW · Traditional Quantimetrix Corp.04/10/2015SE
K131444Ua-Cellular CompleteJJW · Traditional Streck01/29/2014SE
K110846Randox Urinalysis Controls, Levels 1 and 2JJW · Traditional Randox Laboratories Limited09/30/2011SE
K103387Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip…JJW · Traditional ACON Laboratories, Inc.02/02/2011SE
K081908Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2JJW · Traditional Cliniqa Corporation01/16/2009SE
K072640Irispec,Ca/Cb/CcJJW · Abbreviated Iris Diagnostics12/21/2007SE
K070848Liquichek Urinalysis Control (Bi-Level), Control LEVEL1, Level 2,MINIPAK, 435,436,437,435XJJW · Traditional Bio-Rad, Diagnostics Grp.04/25/2007SE
K052242Advia Chemistry Microalbumin ControlsJJW · Abbreviated Bayer Healthcare, LLC10/03/2005SE
K043266Randox Urine ControlsJJW · Traditional Randox Laboratories, Ltd.02/15/2005SE

More from Randox Laboratories, Ltd.

510(k)DeviceDecision
K030600Aution Jet AJ-4270 Urine AnalyzerKQO · Traditional 07/11/2003SE
K013783Aution Max AX-4280 Urinalysis SystemKQO · Traditional 01/18/2002SE

Questions and answers

When was Irispec Urine Chemistry Control Part a and B cleared by the FDA?

Irispec Urine Chemistry Control Part a and B (K945913) received a 510(k) decision of Substantially Equivalent on April 5, 1995, 124 days after the submission was received.

What is the product code of K945913?

The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.