The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Smart Hba1c Assay Kit, Model Dz168b-poc, Smart Hba1c Assay Control Kit, Model Dz168b-con, Smart Hbac1c Analyzer.
| Device ID | K092911 |
| 510k Number | K092911 |
| Device Name: | SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-22 |
| Decision Date | 2010-04-26 |
| Summary: | summary |