Company
CSL Behring GmbH
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2020 | CSL Behring GmbH Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum.
Siemens Material Number (SMN): 10445997 Terminated |
NAO | K060677 |
| May 31, 2018 | CSL Behring GmbH N Latex CDT Kit Terminated |
NAO | K060677 |
| Jun 5, 2017 | CSL Behring GmbH SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 1 Terminated |
CHN | K052788 |
| Jun 5, 2017 | CSL Behring GmbH SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073 Terminated |
CHN | K012470 |
| May 17, 2016 | CSL Behring GmbH Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, hepariniz Terminated |
LPS | K063206 |