ClearanceBrief
510(k) K881355 ยท JHI Visual, Pregnancy Hcg, Prescription Use

AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT

ApplicantAmersham Corp., Arlington Heights IL, US
DecisionSubstantially Equivalent, Jun 8, 1988
ReceivedApr 18, 1988
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K881355

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.