Ramp Ck-Mb Assay
FDA 510(k) K033747 · Response Biomedical Corp.
510(k) numberK033747
Submission
- Device name
- Ramp Ck-Mb Assay
- Applicant
- Response Biomedical Corp.
Burnaby, British Columbia, CA - Received
- December 1, 2003
- Decision date
- May 17, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHX – Fluorometric 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 JHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234005 | Access CK-MBJHX · Traditional | Beckman Coulter, Inc. | 02/16/2024SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | Ortho Clinical Diagnostics | 01/28/2022SE |
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXJHX · Traditional | Radiometer Medical Aps | 09/21/2017SE |
| K120326 | AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…JHX · Traditional | Radiometer Medical Aps | 11/21/2012SE |
| K081360 | Pathfast Ck-Mb-Ii, Pathfast Myo-IiJHX · Traditional | Mitsubishi Kagaku Iatron | 08/17/2009SE |
| K051650 | Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute…JHX · Traditional | Dade Behring, Inc. | 09/08/2005SE |
| K041596 | Architect Stat Ck-Mb ImmunoassayJHX · Traditional | Fisher Diagnostics | 07/21/2004SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | Diagnostic Products Corp. | 01/21/2004SE |
| K030012 | Ck-Mb and Ck-Mb Calibrators on the Access Immunoassay Systems, Models 386371 and 386372JHX · Special | Beckman Coulter, Inc. | 01/17/2003SE |
| K022118 | Immulite Turbo Ck-Mb, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests)JHX · Special | Diagnostic Products Corp. | 07/22/2002SE |
More from Diagnostic Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K093116 | Modification to: Ramp Influenza A/B AssayPSZ · Special | 10/21/2009SE |
| K091235 | Ramp RSV AssayGQG · Traditional | 07/24/2009SE |
| K063662 | Ramp Nt-Probnp AssayNBC · Traditional | 07/21/2008SE |
| K071591 | Ramp Influenza A/B AssayPSZ · Traditional | 04/16/2008SE |
| K033745 | Ramp Troponin I AssayMMI · Traditional | 05/17/2004SE |
| K012040 | Ramp Myoglobin AssayDDR · Traditional | 12/18/2001SE |
Questions and answers
When was Ramp Ck-Mb Assay cleared by the FDA?
Ramp Ck-Mb Assay (K033747) received a 510(k) decision of Substantially Equivalent on May 17, 2004, 168 days after the submission was received.
What is the product code of K033747?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.