Quantitative Control Urine II (Human)
FDA 510(k) K792376 · Environmental Chemical Specialties
510(k) numberK792376
Submission
- Device name
- Quantitative Control Urine II (Human)
- Applicant
- Environmental Chemical Specialties
Mchenry, IL, US - Received
- November 26, 1979
- Decision date
- December 6, 1979
- 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 |
|---|---|---|
| K812635 | Anemia ControlJJY · Traditional | 10/02/1981SE |
| K811810 | Uric Acid TestKNK · Traditional | 07/15/1981SE |
| K811811 | TDM Anti-Convulsant Control Levels I-IiDIF · Traditional | 07/10/1981SE |
| K811809 | Anti-Arrhythmic Control Levels I & IIDIF · Traditional | 07/10/1981SE |
| K803089 | Gamma-Glutamyl Transpeptidase (GGT)JPZ · Traditional | 01/02/1981SE |
| K792377 | Carcinoembryonic Antigen (Cea) ControlDHX · Traditional | 09/26/1980SE |
| K801854 | Spinal Fluid Control(Human)JJX · Traditional | 09/16/1980SE |
| K801061 | Total Protein TestCEK · Traditional | 07/21/1980SE |
| K792375 | Elevated Lipid ControlJJY · Traditional | 12/06/1979SE |
| K792374 | Quantitative Control Urine I (Human)JJW · Traditional | 12/06/1979SE |
Questions and answers
When was Quantitative Control Urine II (Human) cleared by the FDA?
Quantitative Control Urine II (Human) (K792376) received a 510(k) decision of Substantially Equivalent on December 6, 1979, 10 days after the submission was received.
What is the product code of K792376?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.