The following data is part of a premarket notification filed by Hemocue, Inc. with the FDA for Hemocue B-glcose System.
| Device ID | K962415 |
| 510k Number | K962415 |
| Device Name: | HEMOCUE B-GLCOSE SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | HEMOCUE, INC. 23263 MADERO, SUITE A Mission Viejo, CA 92691 |
| Contact | Clas Runnberg |
| Correspondent | Clas Runnberg HEMOCUE, INC. 23263 MADERO, SUITE A Mission Viejo, CA 92691 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-12 |
| Decision Date | 1996-10-15 |