The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Glycoscreen Glycosylated Hemoglobin Assay Kit.
| Device ID | K864643 |
| 510k Number | K864643 |
| Device Name: | GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | PACIFIC HEMOSTASIS 2493 PORTOLA RD. Ventura, CA 93003 |
| Contact | Bick, Phd |
| Correspondent | Bick, Phd PACIFIC HEMOSTASIS 2493 PORTOLA RD. Ventura, CA 93003 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-26 |
| Decision Date | 1987-04-28 |