The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Modification To: Diazyme Potassium Enzymatic Assay, Model Dz113a.
| Device ID | K053566 |
| 510k Number | K053566 |
| Device Name: | MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-22 |
| Decision Date | 2006-02-15 |
| Summary: | summary |