Dade Stratus Troponin-I Control
FDA 510(k) K951888 · Dade Intl., Inc.
510(k) numberK951888
Submission
- Device name
- Dade Stratus Troponin-I Control
- Applicant
- Dade Intl., Inc.
Miami, FL, US - Received
- April 24, 1995
- Decision date
- July 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Dade Stratus Troponin-I Control cleared by the FDA?
Dade Stratus Troponin-I Control (K951888) received a 510(k) decision of Substantially Equivalent on July 13, 1995, 80 days after the submission was received.
What is the product code of K951888?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.