QMS PHENOBARBITAL

Nephelometric Inhibition Immunoassay, Phenobarbital

SERADYN, INC.

The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Qms Phenobarbital.

Pre-market Notification Details

Device IDK934388
510k NumberK934388
Device Name:QMS PHENOBARBITAL
ClassificationNephelometric Inhibition Immunoassay, Phenobarbital
Applicant SERADYN, INC. P.O. BOX 1210 Indianapolis,  IN  46206
ContactAndris Indriksons
CorrespondentAndris Indriksons
SERADYN, INC. P.O. BOX 1210 Indianapolis,  IN  46206
Product CodeLFN  
CFR Regulation Number862.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-09
Decision Date1994-02-25

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