The following data is part of a premarket notification filed by Biosafe Laboratories, Inc. with the FDA for Safe At-home Test Kit For Monitoring Hemoglobin Alc.
| Device ID | K991850 |
| 510k Number | K991850 |
| Device Name: | SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIOSAFE LABORATORIES, INC. 300 KNIGHTSBRIDGE PKWY., #150 Lincolnshire, IL 60069 |
| Contact | Steven P Tyrrell |
| Correspondent | Steven P Tyrrell BIOSAFE LABORATORIES, INC. 300 KNIGHTSBRIDGE PKWY., #150 Lincolnshire, IL 60069 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-01 |
| Decision Date | 1999-11-26 |
| Summary: | summary |