The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Multistat Iii Glucose Test.
Device ID | K771464 |
510k Number | K771464 |
Device Name: | MULTISTAT III GLUCOSE TEST |
Classification | Hexokinase, Glucose |
Applicant | INSTRUMENTATION LABORATORY CO. 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 | 1977-08-04 |
Decision Date | 1977-09-02 |