The following data is part of a premarket notification filed by General Atomics with the FDA for Diazyme Ldl-cholesterol Reagent, Calibrator And Controls.
| Device ID | K072523 |
| 510k Number | K072523 |
| Device Name: | DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | GENERAL ATOMICS 12889 GREGG COURT Poway, CA 92064 |
| Contact | Charles Yu |
| Correspondent | Charles Yu GENERAL ATOMICS 12889 GREGG COURT Poway, CA 92064 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-07 |
| Decision Date | 2008-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091996 | K072523 | 000 |
| 05060500090869 | K072523 | 000 |
| 05060500090852 | K072523 | 000 |
| 05060500090845 | K072523 | 000 |