The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Tox A/b Quick Chek.
| Device ID | K050891 |
| 510k Number | K050891 |
| Device Name: | TOX A/B QUICK CHEK |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
| Contact | David M Lyerly |
| Correspondent | David M Lyerly TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-08 |
| Decision Date | 2005-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002257 | K050891 | 000 |
| 00857031002042 | K050891 | 000 |