FPR PHENYTOIN KIT

Radioimmunoassay, Diphenylhydantoin

COLONY LABORATORIES, INC.

The following data is part of a premarket notification filed by Colony Laboratories, Inc. with the FDA for Fpr Phenytoin Kit.

Pre-market Notification Details

Device IDK894527
510k NumberK894527
Device Name:FPR PHENYTOIN KIT
ClassificationRadioimmunoassay, Diphenylhydantoin
Applicant COLONY LABORATORIES, INC. 1220 NINETEENTH STREET, N.W. FOURTH FLOOR Washington,  DC  20036
ContactDale B Hinson
CorrespondentDale B Hinson
COLONY LABORATORIES, INC. 1220 NINETEENTH STREET, N.W. FOURTH FLOOR Washington,  DC  20036
Product CodeDLP  
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-20
Decision Date1989-09-25

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