510(k) K001005 ยท JIS Calibrator, Primary
WAKO HDL-C/LDL-C CALIBRATOR
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Jun 1, 2000 |
| Received | Mar 29, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001005
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2020 | Fujifilm Medical Systems U.S.A., Inc. Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein Terminated |
JIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.