FPR CARBAMAZEPINE CALIBRATOR KIT

Calibrators, Drug Specific

COLONY LABORATORIES, INC.

The following data is part of a premarket notification filed by Colony Laboratories, Inc. with the FDA for Fpr Carbamazepine Calibrator Kit.

Pre-market Notification Details

Device IDK894520
510k NumberK894520
Device Name:FPR CARBAMAZEPINE CALIBRATOR KIT
ClassificationCalibrators, Drug Specific
Applicant COLONY LABORATORIES, INC. 1220 NINETEENTH STREET, N.W. FOURTH FLOOR Washington,  DC  20036
ContactDale B Hinson
CorrespondentDale B Hinson
COLONY LABORATORIES, INC. 1220 NINETEENTH STREET, N.W. FOURTH FLOOR Washington,  DC  20036
Product CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-20
Decision Date1989-08-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.