Uric Acid Reagent (Product #88219)
FDA 510(k) K883404 · Hichem Diagnostics
510(k) numberK883404
Submission
- Device name
- Uric Acid Reagent (Product #88219)
- Applicant
- Hichem Diagnostics
Brea, CA, US - Received
- August 11, 1988
- Decision date
- September 13, 1988
- 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 |
|---|---|---|
| K981794 | Hichem Calcium Reagent KitCJY · Traditional | 07/29/1998SE |
| K963383 | Hichem Alp/Amp Reagent KitCKF · Traditional | 09/23/1996SE |
| K953863 | Hichem Ise Standards Kit 70011JIX · Traditional | 09/06/1995SE |
| K953862 | Hichem Isekci Solution Kit 70010CGZ · Traditional | 09/06/1995SE |
| K953861 | Hichem Ise Intdernal Reference Kit 70009CGZ · Traditional | 09/06/1995SE |
| K953860 | Hichem Ise Diluent Kit 70008CGZ · Traditional | 09/06/1995SE |
| K951751 | Hichem Ast Reagent KitCIT · Traditional | 08/02/1995SE |
| K946192 | Hichem Y-Gt Reagent KitJQB · Traditional | 05/02/1995SE |
| K946022 | Hichem Ldh/L Reagent KitCFJ · Traditional | 02/23/1995SE |
| K941433 | Hi Chem Aqueous Glucose Control, Low, Med, HighJJX · Traditional | 08/02/1994SE |
Questions and answers
When was Uric Acid Reagent (Product #88219) cleared by the FDA?
Uric Acid Reagent (Product #88219) (K883404) received a 510(k) decision of Substantially Equivalent on September 13, 1988, 33 days after the submission was received.
What is the product code of K883404?
The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.