The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Hdl-cholesterol Reagent,calibrator, Controls.
| Device ID | K072395 |
| 510k Number | K072395 |
| Device Name: | DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| 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 | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-27 |
| Decision Date | 2008-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091989 | K072395 | 000 |
| 05060500090838 | K072395 | 000 |
| 05060500090821 | K072395 | 000 |
| 05060500090814 | K072395 | 000 |
| 00850053916250 | K072395 | 000 |