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 | K003306 |
| 510k Number | K003306 |
| Device Name: | C. DIFFICILE TOX A/B II |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | TECHLAB, INC. VPI RESEARCH PARK 1861 PRATT DR. Blacksburg, VA 24060 |
| Contact | David M Lyerly |
| Correspondent | David M Lyerly TECHLAB, INC. VPI RESEARCH PARK 1861 PRATT DR. Blacksburg, VA 24060 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-20 |
| Decision Date | 2000-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002424 | K003306 | 000 |
| 00857031002103 | K003306 | 000 |
| 00857031002219 | K003306 | 000 |
| 00857031002431 | K003306 | 000 |
| 00857031002646 | K003306 | 000 |