The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Glycated Serum Protein Enzymatic Assay Kit.
| Device ID | K042193 |
| 510k Number | K042193 |
| Device Name: | DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Contact | Chong Yuan |
| Correspondent | Chong Yuan DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-12 |
| Decision Date | 2004-10-29 |
| Summary: | summary |