DOA - IMMUNOASSAY CUT-OFF CALIBRATOR

Calibrators, Drug Mixture

MEDI-TECH, INC.

The following data is part of a premarket notification filed by Medi-tech, Inc. with the FDA for Doa - Immunoassay Cut-off Calibrator.

Pre-market Notification Details

Device IDK945289
510k NumberK945289
Device Name:DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
ClassificationCalibrators, Drug Mixture
Applicant MEDI-TECH, INC. 6025 NICOLLE ST. Ventura,  CA  93003
ContactMichael D Bick
CorrespondentMichael D Bick
MEDI-TECH, INC. 6025 NICOLLE ST. Ventura,  CA  93003
Product CodeDKB  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-31
Decision Date1994-12-13

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