The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for C. Difficile Tox A/b Ii.
| Device ID | K030404 |
| 510k Number | K030404 |
| Device Name: | C. DIFFICILE TOX A/B II |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg, VA 24060 -6364 |
| Contact | David A Wall |
| Correspondent | David A Wall TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg, VA 24060 -6364 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-06 |
| Decision Date | 2003-04-24 |
| Summary: | summary |