The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Liquid Stable Enzymatic Lithium Assay, Model Dz116b.
Device ID | K082001 |
510k Number | K082001 |
Device Name: | DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B |
Classification | Atomic Absorption, Lithium |
Applicant | DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
Contact | Abhijit Datta |
Correspondent | Abhijit Datta DIAZYME LABORATORIES 12889 GREGG COURT Poway, CA 92064 |
Product Code | JII |
CFR Regulation Number | 862.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-14 |
Decision Date | 2008-12-05 |