510(k) K981446 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
WAKO AUTOKIT LP(A)
| Applicant | Wako Chemicals USA, Inc., Richmond VA, US |
| Decision | Substantially Equivalent, Mar 9, 1999 |
| Received | Apr 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981446
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2012 | Wako Chemicals USA, Inc. Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo Terminated |
DFC | None listed |
| Aug 25, 2006 | Wako Chemicals, USA Inc Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industrie Terminated |
MMY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.