Uric Acid Rapid Stat Kit
FDA 510(k) K780827 · Pierce Chemical Co.
510(k) numberK780827
Submission
- Device name
- Uric Acid Rapid Stat Kit
- Applicant
- Pierce Chemical Co.
Mchenry, IL, US - Received
- May 19, 1978
- Decision date
- June 13, 1978
- 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 |
|---|---|---|
| K895661 | Glycotest II Glyhb Assay KitLCP · Traditional | 12/07/1989SE |
| K831837 | Clinovative II Diagnostic KitLCP · Traditional | 08/01/1983SE |
| K821360 | Glyco-Gel Test KitLCP · Traditional | 06/02/1982SE |
| K820279 | Glyco-Gel Test KitLCP · Traditional | 04/08/1982SE |
| K781897 | Stat Kit, MicroproteinCEK · Traditional | 01/10/1979SE |
| K780826 | Bilirubin Rapid Stat KitCIG · Traditional | 05/26/1978SE |
| K780825 | Triglyceride C-37 Rapid Stat KitJGY · Traditional | 05/26/1978SE |
| K780512 | Auto/Stat KitCGA · Traditional | 05/03/1978SE |
| K780331 | Cholesterol Rapid Slat Kit HDLCHH · Traditional | 04/06/1978SE |
Questions and answers
When was Uric Acid Rapid Stat Kit cleared by the FDA?
Uric Acid Rapid Stat Kit (K780827) received a 510(k) decision of Substantially Equivalent on June 13, 1978, 25 days after the submission was received.
What is the product code of K780827?
The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.