The following data is part of a premarket notification filed by Trinity Biotech with the FDA for Uni-gold Cryptosporidium.
| Device ID | K121565 |
| 510k Number | K121565 |
| Device Name: | UNI-GOLD CRYPTOSPORIDIUM |
| Classification | Cryptosporidium Spp. |
| Applicant | TRINITY BIOTECH 5919 FARNSWORTH CT. Carlsbad, CA 92008 |
| Contact | Lupe Kagan |
| Correspondent | Lupe Kagan TRINITY BIOTECH 5919 FARNSWORTH CT. Carlsbad, CA 92008 |
| Product Code | MHJ |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-29 |
| Decision Date | 2013-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746359 | K121565 | 000 |
| 05391516746342 | K121565 | 000 |