The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Procalcitonin (pct) Assay, Diazyme Procalcitonin (pct) Calibrator Set, Diazyme Procalcitonin (pct) Control Set.
| Device ID | K162297 |
| 510k Number | K162297 |
| Device Name: | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set |
| Classification | Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission |
| Applicant | Diazyme Laboratories 12889 Gregg Court Poway, CA 92130 |
| Contact | Abhijit Datta |
| Correspondent | Abhijit Datta Diazyme Laboratories 12889 Gregg Court Poway, CA 92130 |
| Product Code | PTF |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-16 |
| Decision Date | 2017-04-18 |