The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Glyc-affin Gp.
| Device ID | K904814 |
| 510k Number | K904814 |
| Device Name: | GLYC-AFFIN GP |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Contact | Loren F Hazelwood |
| Correspondent | Loren F Hazelwood ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-24 |
| Decision Date | 1990-12-26 |