Uric Acid Reagent Set(Enzymatic
FDA 510(k) K821214 · Omega Medical Electronics
510(k) numberK821214
Submission
- Device name
- Uric Acid Reagent Set(Enzymatic
- Applicant
- Omega Medical Electronics
Mchenry, IL, US - Received
- April 27, 1982
- Decision date
- May 21, 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 |
|---|---|---|
| K823691 | Phosphorus Reagent SetCEO · Traditional | 01/07/1983SE |
| K821212 | Urea Nitrogen Reagent SetCDW · Traditional | 07/22/1982SE |
| K821206 | Sgpt-Uv Reagent SetCKA · Traditional | 07/22/1982SE |
| K821204 | Glucose(Enzymatic) Reagent SetCGA · Traditional | 07/22/1982SE |
| K821208 | Sgot-Uv Reagent SetCIT · Traditional | 07/20/1982SE |
| K821205 | Triglyceride Reagent SetCDT · Traditional | 07/20/1982SE |
| K821201 | Ldh-Uv Reagent SetCFJ · Traditional | 07/20/1982SE |
| K821209 | Sgot Reagent SetCIQ · Traditional | 07/14/1982SE |
| K821207 | SGPT Reagent SetCKD · Traditional | 07/14/1982SE |
| K821213 | Uric Acid Reagent SetCDH · Traditional | 07/13/1982SE |
Questions and answers
When was Uric Acid Reagent Set(Enzymatic cleared by the FDA?
Uric Acid Reagent Set(Enzymatic (K821214) received a 510(k) decision of Substantially Equivalent on May 21, 1982, 24 days after the submission was received.
What is the product code of K821214?
The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.