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 |