The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Cholesterol.
Device ID | K880237 |
510k Number | K880237 |
Device Name: | CHOLESTEROL |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont, IL 60559 |
Contact | Arun Sanghavi |
Correspondent | Arun Sanghavi TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont, IL 60559 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-20 |
Decision Date | 1988-04-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CHOLESTEROL 73837165 1611220 Dead/Cancelled |
KSF MEDICAL PUBLISHING COMPANY, INC. 1989-11-09 |
CHOLESTEROL 73783518 not registered Dead/Abandoned |
DAWN FOOD PRODUCTS, INC. 1989-02-27 |