The following data is part of a premarket notification filed by Techlab Inc., Corporate Research Center with the FDA for Asca-chek.
Device ID | K071711 |
510k Number | K071711 |
Device Name: | ASCA-CHEK |
Classification | Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) |
Applicant | TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. Blacksburg, VA 24060 -6358 |
Contact | Charles Pennington |
Correspondent | Charles Pennington TECHLAB INC., CORPORATE RESEARCH CENTER 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 | 2007-06-22 |
Decision Date | 2007-11-07 |
Summary: | summary |