LD-1(IMMUNO) SEPARATION SET

Chromatographic Separation, Lactate Dehydrogenase Isoenzymes

SERAGEN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for Ld-1(immuno) Separation Set.

Pre-market Notification Details

Device IDK851521
510k NumberK851521
Device Name:LD-1(IMMUNO) SEPARATION SET
ClassificationChromatographic Separation, Lactate Dehydrogenase Isoenzymes
Applicant SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis,  IN  46206
ContactMichael J Sullivan
CorrespondentMichael J Sullivan
SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis,  IN  46206
Product CodeCEX  
CFR Regulation Number862.1445 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-15
Decision Date1985-05-10

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