The following data is part of a premarket notification filed by Hemocue, Inc. with the FDA for Hemocue B-glucose System.
| Device ID | K943432 |
| 510k Number | K943432 |
| Device Name: | HEMOCUE B-GLUCOSE SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | HEMOCUE, INC. 23263 MADERO, SUITE A Mission Viejo, CA 92691 |
| Contact | R.j. Slomoff |
| Correspondent | R.j. Slomoff HEMOCUE, INC. 23263 MADERO, SUITE A Mission Viejo, CA 92691 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-15 |
| Decision Date | 1995-01-17 |