Iri Spec Urinalysis Control
FDA 510(k) K832713 · Intl. Remote Imaging Systems
510(k) numberK832713
Submission
- Device name
- Iri Spec Urinalysis Control
- Applicant
- Intl. Remote Imaging Systems
Mchenry, IL, US - Received
- August 12, 1983
- Decision date
- December 22, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K170091 | UA-Cellular CompleteJJW · Traditional | Streck | 02/09/2017SE |
| K142262 | Aution Check PlusJJW · Traditional | Quantimetrix Corp. | 04/10/2015SE |
| K131444 | Ua-Cellular CompleteJJW · Traditional | Streck | 01/29/2014SE |
| K110846 | Randox Urinalysis Controls, Levels 1 and 2JJW · Traditional | Randox Laboratories Limited | 09/30/2011SE |
| K103387 | Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip…JJW · Traditional | ACON Laboratories, Inc. | 02/02/2011SE |
| K081908 | Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2JJW · Traditional | Cliniqa Corporation | 01/16/2009SE |
| K072640 | Irispec,Ca/Cb/CcJJW · Abbreviated | Iris Diagnostics | 12/21/2007SE |
| K070848 | Liquichek Urinalysis Control (Bi-Level), Control LEVEL1, Level 2,MINIPAK, 435,436,437,435XJJW · Traditional | Bio-Rad, Diagnostics Grp. | 04/25/2007SE |
| K052242 | Advia Chemistry Microalbumin ControlsJJW · Abbreviated | Bayer Healthcare, LLC | 10/03/2005SE |
| K043266 | Randox Urine ControlsJJW · Traditional | Randox Laboratories, Ltd. | 02/15/2005SE |
More from Randox Laboratories, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K022774 | Iq 200 SystemLKM · Traditional | 10/21/2002SE |
| K000373 | 939UDX Urine Pathology SystemLKM · Traditional | 04/14/2000SE |
| K972141 | The Yellow Iris Urinalysis WorkstationKQO · Traditional | 08/25/1997SE |
| K953116 | White Iris Leukocyte Differential AnalyzerGKZ · Traditional | 05/13/1996SE |
| K960054 | 900UDX Urine Pathology SystemKQO · Traditional | 03/22/1996SE |
| K954006 | Yellow Iris Urinalysis Workstation W/Iriscope Body Fluid Analysis CapabilityGKL · Traditional | 03/12/1996SE |
| K943463 | The Yellow IrisKQO · Traditional | 09/20/1994SE |
| K934539 | The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis CapabilityGKL · Traditional | 03/30/1994SE |
| K914256 | Yellow Iris Urinalysis Wrksta W/Iriscope Bdy FluGKL · Traditional | 05/01/1992SE |
| K893530 | Iristain Formula 2, Parts 1 and 2JTS · Traditional | 06/13/1989SE |
Questions and answers
When was Iri Spec Urinalysis Control cleared by the FDA?
Iri Spec Urinalysis Control (K832713) received a 510(k) decision of Substantially Equivalent on December 22, 1983, 132 days after the submission was received.
What is the product code of K832713?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.