The following data is part of a premarket notification filed by General Atomics with the FDA for Diazyme Lp(a) Assay.
| Device ID | K082488 |
| 510k Number | K082488 |
| Device Name: | DIAZYME LP(A) ASSAY |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | GENERAL ATOMICS 12889 GREGG COURT Poway, CA 92064 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta GENERAL ATOMICS 12889 GREGG COURT Poway, CA 92064 |
| Product Code | DFC |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-28 |
| Decision Date | 2009-01-13 |
| Summary: | summary |