PRIMIDONE (FPIA) CALIBRATOR KIT

Calibrators, Drug Specific

TUDOR LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK895568
510k NumberK895568
Device Name:PRIMIDONE (FPIA) CALIBRATOR KIT
ClassificationCalibrators, Drug Specific
Applicant TUDOR LABORATORIES, INC. 5910 N. CENTRAL EXPRESSWAY SUITE 1070 - LOCK BOX 45 Dallas,  TX  75206
ContactDowben, Md
CorrespondentDowben, Md
TUDOR LABORATORIES, INC. 5910 N. CENTRAL EXPRESSWAY SUITE 1070 - LOCK BOX 45 Dallas,  TX  75206
Product CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-06
Decision Date1989-09-28

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