The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for C. Diff Quik Chek Complete.
Device ID | K082499 |
510k Number | K082499 |
Device Name: | C. DIFF QUIK CHEK COMPLETE |
Classification | Reagents, Clostridium Difficile Toxin |
Applicant | TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
Contact | Charles Pennington |
Correspondent | Charles Pennington 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 | 2008-08-29 |
Decision Date | 2009-03-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857031002387 | K082499 | 000 |
00857031002370 | K082499 | 000 |
00857031002158 | K082499 | 000 |
00857031002059 | K082499 | 000 |
00857031002554 | K082499 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
C. DIFF QUIK CHEK COMPLETE 77466957 3597654 Live/Registered |
TechLab, Inc. 2008-05-06 |