Vidas Creatine Kinase MB Assay 30-421
FDA 510(k) K962549 · Biomerieux Vitek, Inc.
510(k) numberK962549
Submission
- Device name
- Vidas Creatine Kinase MB Assay 30-421
- Applicant
- Biomerieux Vitek, Inc.
Rockland, MA, US - Received
- June 28, 1996
- Decision date
- August 30, 1996
- 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
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| 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 |
| K033747 | Ramp Ck-Mb AssayJHX · Traditional | Response Biomedical Corp. | 05/17/2004SE |
| 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 |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973819 | Vidas D-Dimer (DD) AssayDAP · Traditional | 03/10/1998SE |
| K972895 | Vidas Rotavirus (RTV) AssayLIQ · Traditional | 10/03/1997SE |
| K965092 | Vidas Rotavirus AssayLIQ · Traditional | 05/05/1997SE |
| K964887 | Vidas C. Difficile Toxin a II AssayLLH · Traditional | 04/08/1997SE |
| K955627 | Vidas Chlamydia Blocking AssayLJC · Traditional | 10/07/1996SE |
| K962609 | Gram Negative Identification Plus CardLRH · Traditional | 08/30/1996SE |
| K952095 | Vitek Gram Positive Identification Card (Gpi)LQL · Traditional | 03/12/1996SE |
| K955647 | Vidas Estradiol II (E2II) AssayCHP · Traditional | 02/06/1996SE |
| K943812 | Vidas Lyme Screen IILSR · Traditional | 06/13/1995SE |
| K942050 | Hemolab Cofac IxGJT · Traditional | 05/19/1995SE |
Questions and answers
When was Vidas Creatine Kinase MB Assay 30-421 cleared by the FDA?
Vidas Creatine Kinase MB Assay 30-421 (K962549) received a 510(k) decision of Substantially Equivalent on August 30, 1996, 63 days after the submission was received.
What is the product code of K962549?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.