Toyo Jozo Uric Acid Test
FDA 510(k) K842103 · Advocacy International, Ltd.
510(k) numberK842103
Submission
- Device name
- Toyo Jozo Uric Acid Test
- Applicant
- Advocacy International, Ltd.
Washington, DC, US - Received
- May 25, 1984
- Decision date
- August 12, 1984
- 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 |
|---|---|---|
| K874027 | Lipase UV [Toyo]CHI · Traditional | 05/27/1988SE |
| K873792 | Sepacell R-500 and Sepacell R-500ACAK · Traditional | 01/19/1988SE |
| K855251 | Modification Asahi New Pan-Series HemofiltersKDI · Traditional | 02/04/1986SE |
| K855212 | Asahi Am Series DialyzersFJI · Traditional | 01/21/1986SE |
| K854259 | Sepacell R-500 & Sepacell R-500ACAK · Traditional | 01/08/1986SE |
| K842104 | Toyo Jozo G-Gtp TestJPZ · Traditional | 08/10/1984SE |
| K830231 | Asahi Hollow Fiber Kidneys, Am-SeriesKOC · Traditional | 03/17/1983SE |
| K830183 | Asahi Hollow Fiber Kidneys NR SeriesKOC · Traditional | 03/17/1983SE |
| K823733 | Eiken Kizai Artificial Kidney Blood CirKOC · Traditional | 01/14/1983SE |
| K813037 | Flowguard Catheters & CannalaeDWF · Traditional | 12/14/1981SE |
Questions and answers
When was Toyo Jozo Uric Acid Test cleared by the FDA?
Toyo Jozo Uric Acid Test (K842103) received a 510(k) decision of Substantially Equivalent on August 12, 1984, 79 days after the submission was received.
What is the product code of K842103?
The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.