ClearanceBrief
510(k) K972070 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)

NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS

ApplicantNichols Institute Diagnostics, San Juan Capistrano CA, US
DecisionSubstantially Equivalent, Jun 26, 1997
ReceivedJun 3, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K972070

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.