The following data is part of a premarket notification filed by Trinity Biotech Usa with the FDA for Captia Measles Igm.
| Device ID | K140455 |
| 510k Number | K140455 |
| Device Name: | CAPTIA MEASLES IGM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubeola Igm |
| Applicant | TRINITY BIOTECH USA 2823 Girts Rd Jamestown, NY 14701 |
| Contact | Bonnie B Dejoy |
| Correspondent | Bonnie B Dejoy TRINITY BIOTECH USA 2823 Girts Rd Jamestown, NY 14701 |
| Product Code | PCL |
| CFR Regulation Number | 866.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-24 |
| Decision Date | 2014-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516743655 | K140455 | 000 |