The following data is part of a premarket notification filed by Trinity Biotech with the FDA for Unigold Giardia.
| Device ID | K120001 |
| 510k Number | K120001 |
| Device Name: | UNIGOLD GIARDIA |
| Classification | Giardia Spp. |
| Applicant | TRINITY BIOTECH 5919 FARNSWORTH CT. California, CA 92008 |
| Contact | Lupe Kagan |
| Correspondent | Lupe Kagan TRINITY BIOTECH 5919 FARNSWORTH CT. California, CA 92008 |
| Product Code | MHI |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-03 |
| Decision Date | 2013-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746335 | K120001 | 000 |
| 05391516746328 | K120001 | 000 |