DIGOXIN (FPIA) CALIBRATOR KIT

Calibrators, Drug Specific

WINDSOR LABORATORIES, INC.

The following data is part of a premarket notification filed by Windsor Laboratories, Inc. with the FDA for Digoxin (fpia) Calibrator Kit.

Pre-market Notification Details

Device IDK870389
510k NumberK870389
Device Name:DIGOXIN (FPIA) CALIBRATOR KIT
ClassificationCalibrators, Drug Specific
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 CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-30
Decision Date1987-04-01

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