The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for C. Diff Chek - 60.
| Device ID | K030992 |
| 510k Number | K030992 |
| Device Name: | C. DIFF CHEK - 60 |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | TECHLAB, INC. 1861 PRATT DR., STE. 1030 Blacksburg, VA 24060 -6364 |
| Contact | David M Lyerly |
| Correspondent | David M Lyerly 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 | 2003-03-28 |
| Decision Date | 2003-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002233 | K030992 | 000 |
| 00857031002226 | K030992 | 000 |
| 00857031002110 | K030992 | 000 |
| 00857031002448 | K030992 | 000 |
| 00857031002660 | K030992 | 000 |