Kodak Ektachem DT Slides (CKMB)
FDA 510(k) K875192 · Eastman Kodak Company
510(k) numberK875192
Submission
- Device name
- Kodak Ektachem DT Slides (CKMB)
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- December 17, 1987
- Decision date
- February 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHY – Colorimetric Method, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K143720 | Dimension Vista MMB AssayJHY · Traditional | Siemens Healthcare Diagnostics | 09/18/2015SE |
| K130080 | Easyra Ck-Mb Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP…JHY · Traditional | Medica Corporation | 05/13/2014SE |
| K140404 | Elecsys Ck-Mb Stat ImmunoassayJHY · Special | Roche Diagnostics | 05/08/2014SE |
| K132571 | Elecsys Ck-Mb Stat Immunoassay, Elecsys Ck-Mb ImmunoassayJHY · Traditional | Roche Diagnostics | 10/18/2013SE |
| K070835 | Olympus Ck-Mb ReagentJHY · Traditional | Olympus Life & Material Science Europa GmbH (Irish | 06/04/2007SE |
| K022757 | Spife CK Kit, Model 3332, 3333JHY · Traditional | Helena Laboratories | 10/11/2002SE |
| K022654 | Modification to Elecsys Ck-Mb Stat, Elecsys Ck-MbJHY · Special | Roche Diagnostics Corp. | 08/29/2002SE |
| K974421 | Elecsys Ck-Mb StatJHY · Traditional | Boehringer Mannheim Corp. | 12/17/1997SE |
| K970343 | MMB MethodJHY · Traditional | Dade Chemistry Systems, Inc. | 02/14/1997SE |
| K961412 | Ck-Mb Method for the Technicon Immuno 1 System In-VitroJHY · Traditional | Bayer Corp. | 06/18/1996SE |
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| 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 |
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Questions and answers
When was Kodak Ektachem DT Slides (CKMB) cleared by the FDA?
Kodak Ektachem DT Slides (CKMB) (K875192) received a 510(k) decision of Substantially Equivalent on February 24, 1988, 69 days after the submission was received.
What is the product code of K875192?
The FDA product code is JHY – Colorimetric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.