The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Pct, Access Pct Calibrators.
| Device ID | K192271 |
| 510k Number | K192271 |
| Device Name: | Access PCT, Access PCT Calibrators |
| Classification | Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission |
| Applicant | Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 -1084 |
| Contact | Jennifer Bennett |
| Correspondent | Jennifer Bennett Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 -1084 |
| Product Code | PTF |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2019-11-26 |
| Summary: | summary |