NML Ck-Mb Ria
FDA 510(k) K812759 · Nuclear Medical Laboratories, Inc.
510(k) numberK812759
Submission
- Device name
- NML Ck-Mb Ria
- Applicant
- Nuclear Medical Laboratories, Inc.
Mchenry, IL, US - Received
- October 1, 1981
- Decision date
- October 19, 1981
- 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 |
|---|---|---|
| K852438 | NML TSH IrmaJLW · Traditional | 07/12/1985SE |
| K844583 | Tsh-StatJLW · Traditional | 03/05/1985SE |
| K840466 | NML Cortisol RiaCGR · Traditional | 03/30/1984SE |
| K840589 | Tri-Tube RiaKHQ · Traditional | 03/09/1984SE |
| K832892 | Modified Chorio-ShureJHI · Traditional | 10/28/1983SE |
| K832002 | NML-5010/5020 Multi-Detector SystemJJJ · Traditional | 08/08/1983SE |
| K823679 | NML 6000 CTJQP · Traditional | 01/07/1983SE |
| K823053 | Nml-Tetra-Tube RiaCDX · Traditional | 11/10/1982SE |
| K822298 | Diagnostic Radioimmunoassay for QuantiJFH · Traditional | 09/02/1982SE |
| K820523 | Chorio-QuantJHI · Traditional | 03/15/1982SE |
Questions and answers
When was NML Ck-Mb Ria cleared by the FDA?
NML Ck-Mb Ria (K812759) received a 510(k) decision of Substantially Equivalent on October 19, 1981, 18 days after the submission was received.
What is the product code of K812759?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.