Destiny Max Coagulation Analyzer
FDA 510(k) K083896 · Trinity Biotech
510(k) numberK083896
Submission
- Device name
- Destiny Max Coagulation Analyzer
- Applicant
- Trinity Biotech
Jamestown, NY, US - Received
- December 29, 2008
- Decision date
- July 2, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JPA – System, Multipurpose For In Vitro Coagulation Studies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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Questions and answers
When was Destiny Max Coagulation Analyzer cleared by the FDA?
Destiny Max Coagulation Analyzer (K083896) received a 510(k) decision of Substantially Equivalent on July 2, 2009, 185 days after the submission was received.
What is the product code of K083896?
The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.