Kodak Ekta-Chem Clinical Chem. Slides
FDA 510(k) K802376 · Eastman Kodak Company
510(k) numberK802376
Submission
- Device name
- Kodak Ekta-Chem Clinical Chem. Slides
- Applicant
- Eastman Kodak Company
Walker, MI, US - Received
- September 30, 1980
- Decision date
- October 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHS – Coulometric Method, Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1160
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K926320 | Reflab System Pack Liquid CO2 ReagentCHS · Traditional | Medical Analysis Systems, Inc. | 02/03/1993SE |
| K911838 | Roche Reagent for C02CHS · Traditional | Roche Diagnostic Systems, Inc. | 07/19/1991SE |
| K860660 | Amresco Flow Pac Carbon Dioxide (CO2) ReagentsCHS · Traditional | Amresco, Inc. | 03/14/1986SE |
| K841080 | Technicon RA-1000 Sys CO2CHS · Traditional | Technicon Instruments Corp. | 05/02/1984SE |
| K811257 | Corning 965 Carbon Dioxide AnalyzerCHS · Traditional | Corning Medical & Scientific | 05/27/1981SE |
More from Corning Medical & Scientific
| 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 Ekta-Chem Clinical Chem. Slides cleared by the FDA?
Kodak Ekta-Chem Clinical Chem. Slides (K802376) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 23 days after the submission was received.
What is the product code of K802376?
The FDA product code is CHS – Coulometric Method, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.