The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Clostridium Difficile Toxin/antitoxin Kit.
| Device ID | K923463 |
| 510k Number | K923463 |
| Device Name: | CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | TECHLAB, INC. 555 13TH ST. SUITE 1109 Washington, DC 20004 |
| Contact | Patricia Shrader |
| Correspondent | Patricia Shrader TECHLAB, INC. 555 13TH ST. SUITE 1109 Washington, DC 20004 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-14 |
| Decision Date | 1993-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002066 | K923463 | 000 |