The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Hs Crp Assay Kit / Calibrator Set / Control Set.
Device ID | K103557 |
510k Number | K103557 |
Device Name: | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET |
Classification | C-reactive Protein, Antigen, Antiserum, And Control |
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 | DCK |
Subsequent Product Code | JIT |
Subsequent Product Code | JJX |
CFR Regulation Number | 866.5270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-02 |
Decision Date | 2011-04-27 |
Summary: | summary |