Isoscreen-Ck Confirmatory Kit
FDA 510(k) K895870 · Roche Diagnostic Systems, Inc.
510(k) numberK895870
Submission
- Device name
- Isoscreen-Ck Confirmatory Kit
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- October 4, 1989
- Decision date
- December 1, 1989
- 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Bayer Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Isoscreen-Ck Confirmatory Kit cleared by the FDA?
Isoscreen-Ck Confirmatory Kit (K895870) received a 510(k) decision of Substantially Equivalent on December 1, 1989, 58 days after the submission was received.
What is the product code of K895870?
The FDA product code is JHY – Colorimetric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.