The following data is part of a premarket notification filed by Hemocue Ab with the FDA for Hemocue Glucose 201 Rt Analyzer Mdl 120731, Hemocue Glucose 201 Rt Microcurettes Mdl 110712.
| Device ID | K060765 |
| 510k Number | K060765 |
| Device Name: | HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | HEMOCUE AB 40 EMPIRE DRIVE Lake Forest, CA 92630 |
| Contact | Allen White |
| Correspondent | Allen White HEMOCUE AB 40 EMPIRE DRIVE Lake Forest, CA 92630 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-21 |
| Decision Date | 2006-09-06 |
| Summary: | summary |