ClearanceBrief
510(k) K970188 ยท CFT Radioimmunoassay, Prolactin (Lactogen)

SEALITE SCIENCES, INC. AQUALITE PROLACTIN

ApplicantSealite Sciences, Inc., Norcross GA, US
DecisionSubstantially Equivalent, Feb 20, 1997
ReceivedJan 17, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K970188

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.