Uricacid
FDA 510(k) K821741 · Biodynamics Corp.
510(k) numberK821741
Submission
- Device name
- Uricacid
- Applicant
- Biodynamics Corp.
Mchenry, IL, US - Received
- June 14, 1982
- Decision date
- July 2, 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 |
|---|---|---|
| K051675 | Biodynamics Bia 500 Biompedance Body Composition AnalyzerMNW · Traditional | 03/16/2006SE |
| K884033 | Biodynamics Model 200 Body Composition AnalyzerDSB · Traditional | 11/17/1988SE |
| K881631 | Biodynamics Autotransfusion ReservoirCAC · Traditional | 09/09/1988SE |
| K881968 | Biodynamics Model BI-400 Body Composition AnalyzerDSB · Traditional | 07/28/1988SE |
| K874361 | Biodynamics Model BI-300 Body Composition AnalyzerDSB · Traditional | 03/16/1988SE |
| K873807 | Autotransfusion ApparatusCAC · Traditional | 03/09/1988SE |
| K874034 | ADR-22 Automatic Dialyzer ReprocessorLIF · Traditional | 10/23/1987SE |
| K870052 | Infumix Mixing ContainerKPE · Traditional | 02/27/1987SE |
| K822716 | Universal CentrifugeJPI · Traditional | 09/30/1982SE |
| K822715 | Platelet CentrifugeJQC · Traditional | 09/30/1982SE |
Questions and answers
When was Uricacid cleared by the FDA?
Uricacid (K821741) received a 510(k) decision of Substantially Equivalent on July 2, 1982, 18 days after the submission was received.
What is the product code of K821741?
The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.