Kodak Ektachem Clinical Chemistry Slides (Uric)
FDA 510(k) K932728 · Eastman Kodak Company
510(k) numberK932728
Submission
- Device name
- Kodak Ektachem Clinical Chemistry Slides (Uric)
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- June 7, 1993
- Decision date
- April 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K060550 | Kodak Directview DR 3000 System 64KW/80KW Generators, Models 6551345, 6551386KPR · Special | 03/31/2006SE |
| K060137 | Kodak Eclipse Image Processing SoftwareMQB · Special | 03/16/2006SE |
| K060079 | Kodak Model CR-7400 Digital Radiography SystemMUH · Special | 02/08/2006SE |
| K060055 | Kodak PacsLLZ · Traditional | 02/07/2006SE |
| K053347 | Kodak Carestream PacsLLZ · Special | 01/04/2006SE |
| K051483 | Kodak Directview DR System DetectorMQB · Traditional | 06/21/2005SE |
| K051258 | Kodak Directview DR 7500 System, Model 8791345KPR · Special | 06/01/2005SE |
| K042159 | Kodak Color Medical Imager 1000LMC · Traditional | 09/24/2004SE |
| K042158 | Kodak Medical Imager 300LMC · Traditional | 09/24/2004SE |
| K040378 | Kodak Directview CR CASSETTE/GP/15 X 30 CM, Catalog# 8418253IXA · Traditional | 05/24/2004SE |
Questions and answers
When was Kodak Ektachem Clinical Chemistry Slides (Uric) cleared by the FDA?
Kodak Ektachem Clinical Chemistry Slides (Uric) (K932728) received a 510(k) decision of Substantially Equivalent on April 25, 1994, 322 days after the submission was received.
What is the product code of K932728?
The FDA product code is KNK – Acid, Uric, Uricase (Colorimetric), a Class I (low risk) device regulated under 21 CFR 862.1775.