The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Sodium Enzymatic Assay.
| Device ID | K042189 |
| 510k Number | K042189 |
| Device Name: | DIAZYME SODIUM ENZYMATIC ASSAY |
| Classification | System, Test, Sodium, Enzymatic Method |
| Applicant | DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Contact | Huhan Tran |
| Correspondent | Huhan Tran DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Product Code | MZU |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-12 |
| Decision Date | 2004-10-07 |
| Summary: | summary |