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 |