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 |