The following data is part of a premarket notification filed by Trinity Biotech with the FDA for Destiny Max Coagulation Analyzer.
| Device ID | K083896 |
| 510k Number | K083896 |
| Device Name: | DESTINY MAX COAGULATION ANALYZER |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | TRINITY BIOTECH 2823 GIRTS ROAD Jamestown, NY 14701 |
| Contact | Bonnie B Dejoy |
| Correspondent | Bonnie B Dejoy TRINITY BIOTECH 2823 GIRTS ROAD Jamestown, NY 14701 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15391521421125 | K083896 | 000 |