The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Direct Hba1c Assay (enzymatic, On-board Lysis), Diazyme Direct Hba1c Assay Calibrator Set, Diazyme Direct Hba1c Assay Control Set.
| Device ID | K160762 |
| 510k Number | K160762 |
| Device Name: | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set |
| 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 |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-21 |
| Decision Date | 2016-11-21 |
| Summary: | summary |