The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Potassium Enzymatic Assay Kit.
| Device ID | K042191 |
| 510k Number | K042191 |
| Device Name: | DIAZYME POTASSIUM ENZYMATIC ASSAY KIT |
| Classification | Test, System, Potassium, Enzymatic Method |
| Applicant | DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Contact | Huan Tran |
| Correspondent | Huan Tran DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego, CA 92121 |
| Product Code | MZV |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-12 |
| Decision Date | 2004-10-29 |
| Summary: | summary |