The following data is part of a premarket notification filed by Lilly Research Laboratories with the FDA for Tes-tape.
Device ID | K922207 |
510k Number | K922207 |
Device Name: | TES-TAPE |
Classification | Glucose Oxidase, Glucose |
Applicant | LILLY RESEARCH LABORATORIES LILLY CORPORATE CENTER Indianapolis, IN 46285 |
Contact | M. W Talbott |
Correspondent | M. W Talbott LILLY RESEARCH LABORATORIES LILLY CORPORATE CENTER Indianapolis, IN 46285 |
Product Code | CGA |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-12 |
Decision Date | 1993-06-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TES-TAPE 72023560 0657941 Dead/Expired |
ELI LILLY AND COMPANY 1957-01-31 |