The following data is part of a premarket notification filed by General Atomics with the FDA for Diazyme Homocysteine Enzymatic Assay Kit.
| Device ID | K042448 |
| 510k Number | K042448 |
| Device Name: | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | GENERAL ATOMICS 3550 GENERAL ATOMICS COURT San Diego, CA 92121 |
| Contact | Huan Tran |
| Correspondent | Huan Tran GENERAL ATOMICS 3550 GENERAL ATOMICS COURT San Diego, CA 92121 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-09 |
| Decision Date | 2004-10-29 |