The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Enzymatic Glucose Reagent (hexokinase).
Device ID | K860724 |
510k Number | K860724 |
Device Name: | ENZYMATIC GLUCOSE REAGENT (HEXOKINASE) |
Classification | Hexokinase, Glucose |
Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
Contact | W. C Riddle |
Correspondent | W. C Riddle TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
Product Code | CFR |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-26 |
Decision Date | 1986-04-07 |