Liqui-Ura Chemistry Urine Controls
FDA 510(k) K840618 · Biodiagnostic Intl
510(k) numberK840618
Submission
- Device name
- Liqui-Ura Chemistry Urine Controls
- Applicant
- Biodiagnostic Intl
Mchenry, IL, US - Received
- February 14, 1984
- Decision date
- April 4, 1984
- 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 |
|---|---|---|
| K031296 | Liqui-Heme Glyco A1C AssayLCP · Traditional | 10/15/2004SE |
| K881430 | Liqui-Sera Serum Alcohol ControlsJJX · Traditional | 07/08/1988SE |
| K874459 | Liqui-Sera Spinal Fluid ControlJJY · Traditional | 12/29/1987SE |
| K863849 | Liqui-Sera Combo Ligand/Tdm ControlsJJY · Traditional | 11/24/1986SE |
| K853906 | Liqui-Sera Chemistry Controls (Comprehensive)JJY · Traditional | 10/04/1985SE |
| K853887 | Liqui-Sera Chem. Multiple CalibratorsJIT · Traditional | 09/30/1985SE |
| K842668 | Liqui-Heme Hemoglobin CalibratorsKRZ · Traditional | 03/05/1985SE |
| K834398 | Liqui-Sera TDM CalibratorsDKB · Traditional | 02/03/1984SE |
| K834259 | Liqui-Ura Toxic Urine ControlDIF · Traditional | 01/30/1984SE |
| K831278 | Liqui-Sera Anticonvulsants ControlsDIF · Traditional | 05/27/1983SE |
Questions and answers
When was Liqui-Ura Chemistry Urine Controls cleared by the FDA?
Liqui-Ura Chemistry Urine Controls (K840618) received a 510(k) decision of Substantially Equivalent on April 4, 1984, 50 days after the submission was received.
What is the product code of K840618?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.