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 |