ClearanceBrief
510(k) DEN050002 ยท NSF Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS

ApplicantWako Chemicals USA, Inc., Richmond VA, US
DecisionUnknown, May 19, 2005
ReceivedApr 7, 2005
TypePost-NSE
FDA recordOpen on fda.gov

Recalls that name DEN050002

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.