Creatine Kinase Isoenzyme Substrate Set
FDA 510(k) K771605 · Pfizer Pharmaceuticals
510(k) numberK771605
Submission
- Device name
- Creatine Kinase Isoenzyme Substrate Set
- Applicant
- Pfizer Pharmaceuticals
Mchenry, IL, US - Received
- August 22, 1977
- Decision date
- September 15, 1977
- 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
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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 |
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| K885321 | Water Jel Sterile Gel-Soaked Burn DressingFRO · Traditional | 03/22/1989SN |
| K810427 | Cefotaxime 30MCG Antimicrobial Suscep.JTN · Traditional | 03/31/1981SE |
| K802408 | E-Vac Blood Culture SystemJSC · Traditional | 10/23/1980SE |
| K770801 | Microbio. Prod. Fluorescent AntibodyGMY · Traditional | 05/25/1977SE |
| K770425 | Needles, Sterile, AirwayFMI · Traditional | 04/15/1977SE |
Questions and answers
When was Creatine Kinase Isoenzyme Substrate Set cleared by the FDA?
Creatine Kinase Isoenzyme Substrate Set (K771605) received a 510(k) decision of Substantially Equivalent on September 15, 1977, 24 days after the submission was received.
What is the product code of K771605?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.