Colorimetric Uric Acid Reagent Set
FDA 510(k) K820632 · Biorent Diagnostic, Inc.
510(k) numberK820632
Submission
- Device name
- Colorimetric Uric Acid Reagent Set
- Applicant
- Biorent Diagnostic, Inc.
Walker, MI, US - Received
- March 8, 1982
- Decision date
- March 25, 1982
- 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 |
|---|---|---|
| K832747 | Albumin Reagent SetCIX · Traditional | 10/14/1983SE |
| K823211 | Ck-Uv ReagentJHS · Traditional | 11/22/1982SE |
| K823060 | Hemoglobin ReagentKHG · Traditional | 11/22/1982SE |
| K822494 | Optimized Uv-Gpt Reagent SetCKA · Traditional | 09/21/1982SE |
| K822493 | Optimized Uv-Got Reagent SetCIT · Traditional | 09/21/1982SE |
| K822492 | Optimized Uv-Ldh Reagent SetCFJ · Traditional | 09/17/1982SE |
| K820768 | Colorimetric LDH Reagent SetCFH · Traditional | 04/14/1982SE |
| K813555 | Glucose Enzyme-Color Reagent SetCGA · Traditional | 01/18/1982SE |
| K813244 | UV Uric Acid DeterminationCDO · Traditional | 12/08/1981SE |
| K811760 | Cholesterol DeterminationCHH · Traditional | 07/10/1981SE |
Questions and answers
When was Colorimetric Uric Acid Reagent Set cleared by the FDA?
Colorimetric Uric Acid Reagent Set (K820632) received a 510(k) decision of Substantially Equivalent on March 25, 1982, 17 days after the submission was received.
What is the product code of K820632?
The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.