The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Clostridium Difficile Selective Supple.
| Device ID | K831219 |
| 510k Number | K831219 |
| Device Name: | CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE |
| Classification | Supplement, Culture Media |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSK |
| CFR Regulation Number | 866.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-15 |
| Decision Date | 1983-05-13 |