The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for C. Difficile Tox A/b Ii.
Device ID | K003306 |
510k Number | K003306 |
Device Name: | C. DIFFICILE TOX A/B II |
Classification | Reagents, Clostridium Difficile Toxin |
Applicant | TECHLAB, INC. VPI RESEARCH PARK 1861 PRATT DR. Blacksburg, VA 24060 |
Contact | David M Lyerly |
Correspondent | David M Lyerly TECHLAB, INC. VPI RESEARCH PARK 1861 PRATT DR. Blacksburg, VA 24060 |
Product Code | LLH |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-20 |
Decision Date | 2000-11-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857031002424 | K003306 | 000 |
00857031002103 | K003306 | 000 |
00857031002219 | K003306 | 000 |
00857031002431 | K003306 | 000 |
00857031002646 | K003306 | 000 |