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 |