The following data is part of a premarket notification filed by Hemocue, Inc. with the FDA for Hemocue(r) B-glucose Microcuvette/photometer.
| Device ID | K911141 |
| 510k Number | K911141 |
| Device Name: | HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER |
| Classification | Glucose Oxidase, Glucose |
| Applicant | HEMOCUE, INC. C/O ROBERT JOEL SLOMOF 9229 CRANFORD DRIVE Potomac, MD 20854 |
| Contact | R. J Slomoff |
| Correspondent | R. J Slomoff HEMOCUE, INC. C/O ROBERT JOEL SLOMOF 9229 CRANFORD DRIVE Potomac, MD 20854 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-14 |
| Decision Date | 1991-05-08 |