Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak
FDA 510(k) K981099 · Dade Behring, Inc.
510(k) numberK981099
Submission
- Device name
- Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- March 26, 1998
- Decision date
- May 26, 1998
- 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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Questions and answers
When was Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak cleared by the FDA?
Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak (K981099) received a 510(k) decision of Substantially Equivalent on May 26, 1998, 61 days after the submission was received.
What is the product code of K981099?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.