The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Glycohemosure Hba1c Control.
| Device ID | K032791 |
| 510k Number | K032791 |
| Device Name: | GLYCOHEMOSURE HBA1C CONTROL |
| Classification | Control, Hemoglobin |
| Applicant | QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Contact | Gebhard Neyer |
| Correspondent | Gebhard Neyer QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach, CA 90278 -1205 |
| Product Code | GGM |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-08 |
| Decision Date | 2003-10-30 |
| Summary: | summary |