Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis
FDA 510(k) K031231 · Bio-Rad
510(k) numberK031231
Submission
- Device name
- Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- April 18, 2003
- Decision date
- June 18, 2003
- 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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| 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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Questions and answers
When was Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis cleared by the FDA?
Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis (K031231) received a 510(k) decision of Substantially Equivalent on June 18, 2003, 61 days after the submission was received.
What is the product code of K031231?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.