The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Tox A/b Test.
| Device ID | K971182 |
| 510k Number | K971182 |
| Device Name: | TOX A/B TEST |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | TECHLAB, INC. 1861 PRATT DR. CORPORATE RESEARCH CENTER Blacksburg, VA 24060 -6364 |
| Contact | David M Lyerly |
| Correspondent | David M Lyerly TECHLAB, INC. 1861 PRATT DR. CORPORATE RESEARCH CENTER 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 | 1997-03-31 |
| Decision Date | 1997-07-22 |
| Summary: | summary |