Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2
FDA 510(k) K081908 · Cliniqa Corporation
510(k) numberK081908
Submission
- Device name
- Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2
- Applicant
- Cliniqa Corporation
San Marcos, CA, US - Received
- July 3, 2008
- Decision date
- January 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code JJW
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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 |
| 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 |
| K042446 | Quantify Control and Quantify Plus ControlsJJW · Traditional | Bio-Rad Laboratories, Inc. | 11/02/2004SE |
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| K080973 | Cliniqa Liquid QC Complete Cardiac Marker Control, Levels 1,2, and 3; Cardiac Marker…JJY · Traditional | 06/02/2008SE |
| K070741 | Cliniqa Liquid QC Unassayed and Assayed General Chemistry Control Levels 1, 2, & 3JJY · Traditional | 05/04/2007SE |
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| K060322 | Cliniqa Dry QC Chemistry Control, Levels 1 and 2, Assayed, Cliniqa Dry QC Chemistry…JIT · Traditional | 03/21/2006SE |
| K052679 | Cliniqa Liquid QC Bilirubin Controls Levels 1, 2 & 3; Cliniqa Linical Bilirubin…JJX · Traditional | 11/18/2005SE |
Questions and answers
When was Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2 cleared by the FDA?
Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2 (K081908) received a 510(k) decision of Substantially Equivalent on January 16, 2009, 197 days after the submission was received.
What is the product code of K081908?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.