The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Modification To: Direct Enzymatic Hba1c Assay Kit, Model# Dz168a, Dz168a-cal, Dz168a-con.
Device ID | K070734 |
510k Number | K070734 |
Device Name: | MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON |
Classification | Assay, Glycosylated Hemoglobin |
Applicant | DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
Contact | Abhijit Datta |
Correspondent | Abhijit Datta DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
Product Code | LCP |
CFR Regulation Number | 864.7470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-16 |
Decision Date | 2007-04-09 |