MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H

Albumin, Fitc, Antigen, Antiserum, Control

GOOD BIOTECH CORP.

The following data is part of a premarket notification filed by Good Biotech Corp. with the FDA for Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-l, Control-h.

Pre-market Notification Details

Device IDK050576
510k NumberK050576
Device Name:MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H
ClassificationAlbumin, Fitc, Antigen, Antiserum, Control
Applicant GOOD BIOTECH CORP. 38, 34TH RD. TAICHUNG INDUSTRIAL PARK Taichung,  TW 407
ContactVictor Chiou
CorrespondentVictor Chiou
GOOD BIOTECH CORP. 38, 34TH RD. TAICHUNG INDUSTRIAL PARK Taichung,  TW 407
Product CodeDDZ  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number866.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-07
Decision Date2005-04-21
Summary:summary

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