The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Liquid Stable Enzymatic Sodium Assay, Model Dz114b.
| Device ID | K082763 |
| 510k Number | K082763 |
| Device Name: | DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B |
| Classification | System, Test, Sodium, Enzymatic Method |
| 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 | MZU |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-22 |
| Decision Date | 2008-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500092016 | K082763 | 000 |
| 05060500091378 | K082763 | 000 |