510(k) K030545 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
CRP-LATEX (II)X2 SEIKEN ASSAY KIT
| Applicant | Denka Seiken Co., Ltd., Gosen City, Niigata, JP |
| Decision | Substantially Equivalent, Jun 2, 2003 |
| Received | Feb 20, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2017 | Medtest Holdings, Inc. Pointe Scientific CRP(HS) Wide Range Control Set and
Pointe Scientific CRP(HS) Wide Range Standard Set
5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Ra Terminated |
DCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.