Uric, Ua, or Uric Acid
FDA 510(k) K971133 · Carolina Liquid Chemistries Corp.
510(k) numberK971133
Submission
- Device name
- Uric, Ua, or Uric Acid
- Applicant
- Carolina Liquid Chemistries Corp.
Brea, CA, US - Received
- March 27, 1997
- Decision date
- April 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KNK – Acid, Uric, Uricase (Colorimetric)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1775
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KNK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102568 | Uric Acid Model 3P39KNK · Traditional | Abbott Laboratories | 05/06/2011SE |
| K062862 | Olympus Uric Acid Reagent, Model OSR6X98KNK · Traditional | Olympus America, Inc. | 04/06/2007SE |
| K040467 | Vitalab Uric Acid ReagentKNK · Traditional | Clinical Data, Inc. | 03/08/2004SE |
| K031044 | Atac Pak Uric Acid Reagent and Atac CalibratorKNK · Traditional | Clinical Data, Inc. | 07/15/2003SE |
| K022096 | Uric Acid Assay for the Advia Integrated Modular SystemKNK · Traditional | Bayer Diagnostics Corp. | 03/18/2003SE |
| K023550 | Wiener Lab Uricostat Enzimatico Aa LiquidaKNK · Traditional | Wiener Laboratories Saic | 12/09/2002SE |
| K012038 | Jas Uric Acid Liquid ReagentKNK · Traditional | Jas Diagnostics, Inc. | 08/21/2001SE |
| K010421 | Wiener Lab. Uricostat Enzimatico Aa, Models 2X50 ML Catalogue No 1840106 and 4X50 ML…KNK · Traditional | Wiener Laboratories Saic | 04/13/2001SE |
| K993469 | Wako L-Type Ua F TestKNK · Traditional | Wako Chemicals USA, Inc. | 11/09/1999SE |
| K991247 | Uric Acid, Model UA112-01KNK · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
More from A.P. Total Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)…DIO · Traditional | 01/27/2022SE |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)DIO · Traditional | 08/15/2017SE |
| K133519 | Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries…JJE · Traditional | 05/16/2014SE |
| K132711 | Carolina Liquid Chemistries HDL Cholesterol ReagentLBS · Traditional | 05/08/2014SE |
| K972073 | Total Bilirubin ReagentCIG · Traditional | 06/24/1997SE |
| K971907 | Calcium ReagentCIC · Traditional | 06/24/1997SE |
| K971324 | Triglycerides, TG, or TrigCDT · Traditional | 06/20/1997SE |
| K971967 | BunCDQ · Traditional | 06/17/1997SE |
| K971908 | Crea or CreatinineCGX · Traditional | 06/17/1997SE |
| K971467 | Synchron CX Systems Glucose Reagent (Glu)CFR · Traditional | 06/16/1997SE |
Questions and answers
When was Uric, Ua, or Uric Acid cleared by the FDA?
Uric, Ua, or Uric Acid (K971133) received a 510(k) decision of Substantially Equivalent on April 14, 1997, 18 days after the submission was received.
What is the product code of K971133?
The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.