Urine Chemistry Control, Level 1
FDA 510(k) K992576 · Consolidated Technologies, Inc.
510(k) numberK992576
Submission
- Device name
- Urine Chemistry Control, Level 1
- Applicant
- Consolidated Technologies, Inc.
Austin, TX, US - Received
- August 2, 1999
- Decision date
- September 3, 1999
- 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
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 |
|---|---|---|
| K000116 | Qualitrol Urinalysis with Microscopics Control, Levels 1,2 and 3JJY · Traditional | 02/15/2000SE |
| K992578 | Urine Chemistry Control, Level 2JJW · Traditional | 09/03/1999SE |
| K992151 | Reference Material for DELTA-9-THC-COOH in Human UrineLAS · Traditional | 07/14/1999SE |
| K981339 | Quickcheck Lyophilized Chemistry Control Conformance Chemistry Control C3JJY · Traditional | 04/21/1998SE |
| K974699 | Reference Material for Amphetamine/Methamphetamine in Human UrineDKB · Traditional | 01/22/1998SE |
| K973469 | Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed…JJY · Traditional | 09/25/1997SE |
| K972146 | Qualitrol Unassayed H. Pylori Control Set Positive and Negative ControlsLYR · Traditional | 07/08/1997SE |
| K972080 | Qualitrol DHP Immunoassay Control Levels 1,2 and 3, Conformancee Mcc-Ligand Control…JJY · Traditional | 06/18/1997SE |
| K961815 | Qualitrol Ana Control Serum SetLKJ · Traditional | 09/27/1996SE |
| K961550 | Qualitrol Mono Control Serum SetKTN · Traditional | 09/24/1996SE |
Questions and answers
When was Urine Chemistry Control, Level 1 cleared by the FDA?
Urine Chemistry Control, Level 1 (K992576) received a 510(k) decision of Substantially Equivalent on September 3, 1999, 32 days after the submission was received.
What is the product code of K992576?
The FDA product code is JJW – Urinalysis Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.