ClearanceBrief
510(k) K911613 ยท LCR Fluorescent Immunoassay, Tobramycin

VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4

ApplicantExmoor Plastics , Ltd., Taunton, GB
DecisionSubstantially Equivalent, Jun 28, 1991
ReceivedApr 3, 1991
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K911613

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.