Urine Control 1, Cat. No. 903600, Urine Control 2, Cat. No. 904100
FDA 510(k) K000874 · Bio-Rad
510(k) numberK000874
Submission
- Device name
- Urine Control 1, Cat. No. 903600, Urine Control 2, Cat. No. 904100
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- March 20, 2000
- Decision date
- April 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJW – Urinalysis Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| 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 |
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| K081212 | Mrsaselect - Extended IncubationJSO · Traditional | 06/13/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
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Questions and answers
When was Urine Control 1, Cat. No. 903600, Urine Control 2, Cat. No. 904100 cleared by the FDA?
Urine Control 1, Cat. No. 903600, Urine Control 2, Cat. No. 904100 (K000874) received a 510(k) decision of Substantially Equivalent on April 18, 2000, 29 days after the submission was received.
What is the product code of K000874?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.