510(k) K100464 ยท NSF Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
| Applicant | Wako Chemicals USA, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Feb 23, 2011 |
| Received | Feb 18, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100464
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2021 | Fujifilm Medical Systems U.S.A., Inc. TASWako Chip Cassette is part of the Wako TASWako i30 kit Terminated |
NSF | None listed |
| Jul 30, 2013 | Wako Life Sciences, Inc. uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 T Terminated |
DCF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.