Elecsys Ck-Mb Stat
FDA 510(k) K974421 · Boehringer Mannheim Corp.
510(k) numberK974421
Submission
- Device name
- Elecsys Ck-Mb Stat
- Applicant
- Boehringer Mannheim Corp.
Pleasanton, CA, US - Received
- November 24, 1997
- Decision date
- December 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHY – Colorimetric Method, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHY
| 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 |
| 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 |
| K951638 | Auraflex Ck-Mb 200TEST Pack, Calibrator PackJHY · Traditional | Organon Teknika Corp. | 05/02/1995SE |
More from Organon Teknika Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Elecsys Ck-Mb Stat cleared by the FDA?
Elecsys Ck-Mb Stat (K974421) received a 510(k) decision of Substantially Equivalent on December 17, 1997, 23 days after the submission was received.
What is the product code of K974421?
The FDA product code is JHY – Colorimetric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.