The following data is part of a premarket notification filed by Techlab Inc., Corporate Research Center with the FDA for Shiga Toxin Quik Chek.
| Device ID | K121364 |
| 510k Number | K121364 |
| Device Name: | SHIGA TOXIN QUIK CHEK |
| Classification | Antigens, All Types, Escherichia Coli |
| Applicant | TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
| Contact | Donna T Link |
| Correspondent | Donna T Link TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
| Product Code | GMZ |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2012-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002196 | K121364 | 000 |