Colorimetric Uric Acid Reagent Set
FDA 510(k) K871417 · Biochemical Trade, Inc.
510(k) numberK871417
Submission
- Device name
- Colorimetric Uric Acid Reagent Set
- Applicant
- Biochemical Trade, Inc.
Miami, FL, US - Received
- April 7, 1987
- Decision date
- April 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K942958 | Creatine Kinase MB Determination (UV)JHW · Traditional | 11/21/1994SE |
| K910635 | Total Bilirubin Reagent SetCIG · Traditional | 05/15/1991SE |
| K910296 | Phosphorus (Inorganic) Test SystemCEO · Traditional | 02/27/1991SE |
| K905776 | Albumin Reagent SetCJW · Traditional | 02/26/1991SE |
| K905790 | Total Protein Reagent SetCEK · Traditional | 02/21/1991SE |
| K905650 | Kinetic Alkaline Phosphatase DeterminationCJE · Traditional | 02/13/1991SE |
| K905619 | Creatinine (Rate) Reagent SetCGX · Traditional | 02/13/1991SE |
| K905651 | Kinetic Amylase DeterminationJFJ · Traditional | 01/31/1991SE |
| K905649 | Gamma-Glutamyl Transferase DeterminationJQB · Traditional | 01/30/1991SE |
| K905588 | Creatine Kinase UV Reagent SetJHW · Traditional | 01/17/1991SE |
Questions and answers
When was Colorimetric Uric Acid Reagent Set cleared by the FDA?
Colorimetric Uric Acid Reagent Set (K871417) received a 510(k) decision of Substantially Equivalent on April 22, 1987, 15 days after the submission was received.
What is the product code of K871417?
The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.