ClearanceBrief
510(k) K883601 ยท LLM Test, Antigen, Nuclear, Epstein-Barr Virus

EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550

ApplicantClinical Sciences, Inc., Whippany NJ, US
DecisionSubstantially Equivalent, May 11, 1989
ReceivedAug 23, 1988
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K883601

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.