The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Glucose Hexokinase Diag. Kit.
Device ID | K831560 |
510k Number | K831560 |
Device Name: | GLUCOSE HEXOKINASE DIAG. KIT |
Classification | Hexokinase, Glucose |
Applicant | SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CFR |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-16 |
Decision Date | 1983-07-06 |