The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Clostridium Difficile Tox-a-test.
| Device ID | K914902 |
| 510k Number | K914902 |
| Device Name: | CLOSTRIDIUM DIFFICILE TOX-A-TEST |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | TECHLAB, INC. VPI RESEARCH PARK 1861 PRATT DR. Blacksburg, VA 24060 |
| Contact | Tracy D Wilkins |
| Correspondent | Tracy D Wilkins TECHLAB, INC. VPI RESEARCH 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 | 1991-11-01 |
| Decision Date | 1992-03-04 |