The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Glucokey.
Device ID | K831194 |
510k Number | K831194 |
Device Name: | GLUCOKEY |
Classification | Glucose Oxidase, Glucose |
Applicant | ULSTER SCIENTIFIC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CGA |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-12 |
Decision Date | 1983-10-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GLUCOKEY 98224679 not registered Live/Pending |
iHealth Science LLC 2023-10-15 |
GLUCOKEY 73444123 1295860 Dead/Cancelled |
Ulster Scientific, Inc. 1983-09-16 |