The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Glycated Serum Protein Poc Test Kit.
| Device ID | K133803 |
| 510k Number | K133803 |
| Device Name: | DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-16 |
| Decision Date | 2014-08-06 |
| Summary: | summary |