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 |