GENTAMICIN (FPIA) CALIBRATOR KIT

Calibrator, Primary

WINDSOR LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK861769
510k NumberK861769
Device Name:GENTAMICIN (FPIA) CALIBRATOR KIT
ClassificationCalibrator, Primary
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 CodeJIS  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-07
Decision Date1986-06-25

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