The following data is part of a premarket notification filed by General Atomics with the FDA for Diazyme Lithium Enzymatic Assay Kit.
| Device ID | K033360 |
| 510k Number | K033360 |
| Device Name: | DIAZYME LITHIUM ENZYMATIC ASSAY KIT |
| Classification | Atomic Absorption, Lithium |
| Applicant | GENERAL ATOMICS 3550 GENERAL ATOMICS COURT San Diego, CA 92121 |
| Contact | Chong Yuan |
| Correspondent | Chong Yuan GENERAL ATOMICS 3550 GENERAL ATOMICS COURT San Diego, CA 92121 |
| Product Code | JII |
| CFR Regulation Number | 862.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-21 |
| Decision Date | 2003-12-23 |
| Summary: | summary |