Vitros Immunodiagnostic Products Ck-Mb Reagent Pack ; Vitros Immunodiagnostic Products Ck-Mb Calibrators
FDA 510(k) K993068 · Ortho-Clinical Diagnostics
510(k) numberK993068
Submission
- Device name
- Vitros Immunodiagnostic Products Ck-Mb Reagent Pack ; Vitros Immunodiagnostic Products Ck-Mb Calibrators
- Applicant
- Ortho-Clinical Diagnostics
Rochester, NY, US - Received
- September 13, 1999
- Decision date
- October 4, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | 10/29/2025SE |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent PackLIP · Traditional | 08/28/2024SE |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | 05/08/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | 09/05/2023SE |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent PackDHX · Traditional | 08/23/2023SE |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional | 08/09/2023SE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | 12/12/2022SE |
| K213626 | Vitros AfpLOJ · Traditional | 06/15/2022SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | 01/28/2022SE |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional | 10/04/2021SE |
Questions and answers
When was Vitros Immunodiagnostic Products Ck-Mb Reagent Pack ; Vitros Immunodiagnostic Products Ck-Mb Calibrators cleared by the FDA?
Vitros Immunodiagnostic Products Ck-Mb Reagent Pack ; Vitros Immunodiagnostic Products Ck-Mb Calibrators (K993068) received a 510(k) decision of Substantially Equivalent on October 4, 1999, 21 days after the submission was received.
What is the product code of K993068?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.