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 |