The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Liquid Stable Enzymatic Potassium Assay Kit, Model Dz113c-x, Diazyme Liquid Stable Enzymatic Potassium Assay Cal.
| Device ID | K091455 |
| 510k Number | K091455 |
| Device Name: | DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL |
| Classification | Test, System, Potassium, 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 | MZV |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-18 |
| Decision Date | 2009-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500092009 | K091455 | 000 |
| 05060500091279 | K091455 | 000 |