The following data is part of a premarket notification filed by Primeradx with the FDA for Iceplex C. Difficile Assay Kit, Iceplex System.
| Device ID | K132726 |
| 510k Number | K132726 |
| Device Name: | ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM |
| Classification | C. Difficile Toxin Gene Amplification Assay |
| Applicant | PRIMERADX 171 FORBES BLVD SUITE 1000 Mansfield, MA 02048 |
| Contact | Fayyaz Memnon |
| Correspondent | Fayyaz Memnon PRIMERADX 171 FORBES BLVD SUITE 1000 Mansfield, MA 02048 |
| Product Code | OZN |
| CFR Regulation Number | 866.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-30 |
| Decision Date | 2013-11-29 |
| Summary: | summary |