Dade Stratus Ck-Mb Fluorometric Enzyme Immunoassay
FDA 510(k) K972782 · Dade Intl., Inc.
510(k) numberK972782
Submission
- Device name
- Dade Stratus Ck-Mb Fluorometric Enzyme Immunoassay
- Applicant
- Dade Intl., Inc.
Newark, DE, US - Received
- July 25, 1997
- Decision date
- August 15, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
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Questions and answers
When was Dade Stratus Ck-Mb Fluorometric Enzyme Immunoassay cleared by the FDA?
Dade Stratus Ck-Mb Fluorometric Enzyme Immunoassay (K972782) received a 510(k) decision of Substantially Equivalent on August 15, 1997, 21 days after the submission was received.
What is the product code of K972782?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.