MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY

Cryptosporidium Spp.

ALEXON - TREND, INC.

The following data is part of a premarket notification filed by Alexon - Trend, Inc. with the FDA for Modification To Prospect Cryptosporidium Microtiter Assay.

Pre-market Notification Details

Device IDK982709
510k NumberK982709
Device Name:MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
ClassificationCryptosporidium Spp.
Applicant ALEXON - TREND, INC. 14000 UNITY ST., N.W. Ramsey,  MN  55303 -9115
ContactKen Hood
CorrespondentKen Hood
ALEXON - TREND, INC. 14000 UNITY ST., N.W. Ramsey,  MN  55303 -9115
Product CodeMHJ  
CFR Regulation Number866.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-04
Decision Date1998-09-03

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