The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Apolipoprotein B Assay, Model Dzxxx-x; B Calibrator, Model Dzxxx.
Device ID | K073488 |
510k Number | K073488 |
Device Name: | DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX |
Classification | Apolipoproteins |
Applicant | DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
Contact | Charles Yu |
Correspondent | Charles Yu DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
Product Code | MSJ |
Subsequent Product Code | JIT |
Subsequent Product Code | JJX |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-22 |
Decision Date | 2008-03-07 |
Summary: | summary |