The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Techlab Asca-chek.
| Device ID | K051927 |
| 510k Number | K051927 |
| Device Name: | TECHLAB ASCA-CHEK |
| Classification | Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) |
| Applicant | TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
| Contact | David M Lyerly |
| Correspondent | David M Lyerly TECHLAB, INC. 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
| Product Code | NBT |
| CFR Regulation Number | 866.5785 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-18 |
| Decision Date | 2006-04-06 |
| Summary: | summary |