Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak
FDA 510(k) K984067 · Dade Behring, Inc.
510(k) numberK984067
Submission
- Device name
- Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- November 16, 1998
- Decision date
- January 13, 1999
- 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 (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak cleared by the FDA?
Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak (K984067) received a 510(k) decision of Substantially Equivalent on January 13, 1999, 58 days after the submission was received.
What is the product code of K984067?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.