Creatine Kinase MB Enzyme Immunoassay Kit
FDA 510(k) K884550 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK884550
Submission
- Device name
- Creatine Kinase MB Enzyme Immunoassay Kit
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- October 31, 1988
- Decision date
- February 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHY – Colorimetric Method, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
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Questions and answers
When was Creatine Kinase MB Enzyme Immunoassay Kit cleared by the FDA?
Creatine Kinase MB Enzyme Immunoassay Kit (K884550) received a 510(k) decision of Substantially Equivalent on February 23, 1989, 115 days after the submission was received.
What is the product code of K884550?
The FDA product code is JHY – Colorimetric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.