Linear Enzymatic Uric Acid System
FDA 510(k) K843938 · Simmler, Inc.
510(k) numberK843938
Submission
- Device name
- Linear Enzymatic Uric Acid System
- Applicant
- Simmler, Inc.
St. Louis, MO, US - Received
- October 9, 1984
- Decision date
- October 30, 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 |
|---|---|---|
| K895745 | Sickle Cell Solubility Test KitJBB · Traditional | 11/29/1989SE |
| K874903 | Multichem(R) Y -Glutamyltransferase (Y -Gt)JPZ · Traditional | 02/11/1988SE |
| K874595 | Multichem (R) Magnesium ReagentJGJ · Traditional | 01/21/1988SE |
| K874820 | Multichem HDL Precipitating Reagent #S0914LBR · Traditional | 01/07/1988SE |
| K874812 | Multichem Chloride Reagent S0933CHJ · Traditional | 12/18/1987SE |
| K874311 | Multichem (R) Total BilirubinCIG · Traditional | 11/25/1987SE |
| K874049 | Multichem Albumin Reagent S0902CIX · Traditional | 10/29/1987SE |
| K874038 | Multichem Inorganic Phosphorous S0923CEO · Traditional | 10/28/1987SE |
| K873725 | Multichem Creatinine Reagent S0917CGX · Traditional | 10/20/1987SE |
| K873761 | Multichem Alkaline Phosphatase (S0903)CJE · Traditional | 10/07/1987SE |
Questions and answers
When was Linear Enzymatic Uric Acid System cleared by the FDA?
Linear Enzymatic Uric Acid System (K843938) received a 510(k) decision of Substantially Equivalent on October 30, 1984, 21 days after the submission was received.
What is the product code of K843938?
The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.