The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Cystatin C Assay.
Device ID | K093680 |
510k Number | K093680 |
Device Name: | DIAZYME CYSTATIN C ASSAY |
Classification | Test, Cystatin C |
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 | NDY |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-27 |
Decision Date | 2010-04-08 |