Impres-Mb Reagent a and Reagent B
FDA 510(k) K890543 · Intl. Immunoassay Laboratories, Inc.
510(k) numberK890543
Submission
- Device name
- Impres-Mb Reagent a and Reagent B
- Applicant
- Intl. Immunoassay Laboratories, Inc.
Santa Clara, CA, US - Received
- February 3, 1989
- Decision date
- March 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MBJHX · Traditional | 04/22/1992SE |
| K913349 | Stambi-CkJHW · Traditional | 10/23/1991SE |
| K912231 | Proposed New Use of Instrument System and Test KitJHW · Traditional | 07/08/1991SE |
| K903441 | Mydas(Tm) Brand Solid-Phase Antibody ReagentsJHX · Traditional | 11/06/1990SE |
| K903508 | Labelling Changes to Impres-Mb-XJHW · Traditional | 09/07/1990SE |
| K901450 | Modified Label for Embria-Ck, Quick-Mb/Micromi-MbJHT · Traditional | 05/15/1990SE |
| K890609 | Impres-Mb (Addition of an Optional Test Procedure)CGS · Traditional | 03/16/1989SE |
| K883432 | Immunoccult-LxiKHE · Traditional | 10/31/1988SE |
| K883223 | Check-MmJHS · Traditional | 09/30/1988SE |
| K883222 | Isofor-Mm (TM)JHW · Traditional | 09/30/1988SE |
Questions and answers
When was Impres-Mb Reagent a and Reagent B cleared by the FDA?
Impres-Mb Reagent a and Reagent B (K890543) received a 510(k) decision of Substantially Equivalent on March 13, 1989, 38 days after the submission was received.
What is the product code of K890543?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.