510(k) K052788 ยท LPS Urinary Homocystine (Nonquantitative) Test System
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Mar 29, 2006 |
| Received | Oct 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| Jan 11, 2017 | Siemens Healthcare Diagnostics, Inc. N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD
Product Usage:
In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized pl Terminated |
LPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.