The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Clostridium Difficile Tox-b Test.
| Device ID | K935296 |
| 510k Number | K935296 |
| Device Name: | CLOSTRIDIUM DIFFICILE TOX-B TEST |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | TECHLAB, INC. CORP RES PARK, 1861 PRATT DR. Blacksburg, VA 24060 |
| Contact | Tracy B Wilkins |
| Correspondent | Tracy B Wilkins TECHLAB, INC. CORP RES PARK, 1861 PRATT DR. Blacksburg, VA 24060 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-03 |
| Decision Date | 1994-04-26 |