INNOFLUOR PHENYTOIN CALIBRATOR SET

Calibrators, Drug Specific

INNOTRON OF OREGON, INC.

The following data is part of a premarket notification filed by Innotron Of Oregon, Inc. with the FDA for Innofluor Phenytoin Calibrator Set.

Pre-market Notification Details

Device IDK872142
510k NumberK872142
Device Name:INNOFLUOR PHENYTOIN CALIBRATOR SET
ClassificationCalibrators, Drug Specific
Applicant INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland,  OR  97202
ContactBuck, Phd
CorrespondentBuck, Phd
INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland,  OR  97202
Product CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-03
Decision Date1987-07-21

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