The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Dimension Exl Loci Brahms Procalcitonin (pct).
| Device ID | K220262 |
| 510k Number | K220262 |
| Device Name: | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) |
| Classification | Procalcitonin Assay |
| Applicant | Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, P.O. Box 6101 Mail Stop 514 Newark, DE 19714 |
| Contact | Amy Tyler |
| Correspondent | Amy Tyler Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, P.O. Box 6101 Mail Stop 514 Newark, DE 19714 |
| Product Code | PRI |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414298214 | K220262 | 000 |