The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Modification Of Cdt(tm) Clostridium Test.
| Device ID | K863485 |
| 510k Number | K863485 |
| Device Name: | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Contact | Guinty, Jr |
| Correspondent | Guinty, Jr MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-09-17 |