The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin A.
| Device ID | K974881 |
| 510k Number | K974881 |
| Device Name: | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A |
| Classification | Antigen, C. Difficile |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | John F Bruni |
| Correspondent | John F Bruni BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Product Code | MCB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-30 |
| Decision Date | 1998-03-20 |