ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM

Antigens, Cf (including Cf Control), Adenovirus 1-33

IMMUNO PROBE, INC.

The following data is part of a premarket notification filed by Immuno Probe, Inc. with the FDA for Adenovirus Antigen Detection Elisa Test System.

Pre-market Notification Details

Device IDK972406
510k NumberK972406
Device Name:ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
ClassificationAntigens, Cf (including Cf Control), Adenovirus 1-33
Applicant IMMUNO PROBE, INC. 1306F BAILES LN. Frederick,  MD  21701
ContactWilliam L Boteler
CorrespondentWilliam L Boteler
IMMUNO PROBE, INC. 1306F BAILES LN. Frederick,  MD  21701
Product CodeGOD  
CFR Regulation Number866.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-26
Decision Date1997-12-22
Summary:summary

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