3-(N-MORPHOLINS)-PROPANE Sulfonic Acid
FDA 510(k) K771324 · Corning Medical & Scientific
510(k) numberK771324
Submission
- Device name
- 3-(N-MORPHOLINS)-PROPANE Sulfonic Acid
- Applicant
- Corning Medical & Scientific
Mchenry, IL, US - Received
- July 18, 1977
- Decision date
- September 2, 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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| 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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Questions and answers
When was 3-(N-MORPHOLINS)-PROPANE Sulfonic Acid cleared by the FDA?
3-(N-MORPHOLINS)-PROPANE Sulfonic Acid (K771324) received a 510(k) decision of Substantially Equivalent on September 2, 1977, 46 days after the submission was received.
What is the product code of K771324?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.