The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Trendar.
Device ID | K771000 |
510k Number | K771000 |
Device Name: | TRENDAR |
Classification | Glucose Oxidase, Glucose |
Applicant | HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGA |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-06-03 |
Decision Date | 1977-07-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TRENDAR 72067915 0687116 Dead/Cancelled |
AMERICAN HOME PRODUCTS CORPORATION 1959-02-18 |