CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY

Enzyme Immunoassay, Carbamazepine

WINDSOR LABORATORIES, INC.

The following data is part of a premarket notification filed by Windsor Laboratories, Inc. with the FDA for Carbamazepine Fpia Fluores. Polariza. Immunoassay.

Pre-market Notification Details

Device IDK873282
510k NumberK873282
Device Name:CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
ClassificationEnzyme Immunoassay, Carbamazepine
Applicant WINDSOR LABORATORIES, INC. P.O. BOX 475487 Garland,  TX  75047
ContactGuy W Rucker
CorrespondentGuy W Rucker
WINDSOR LABORATORIES, INC. P.O. BOX 475487 Garland,  TX  75047
Product CodeKLT  
CFR Regulation Number862.3645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-17
Decision Date1987-09-22

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