PROSPECT(TM/CRYPTOSPORIDIUM

Cryptosporidium Spp.

ALEXON, INC.

The following data is part of a premarket notification filed by Alexon, Inc. with the FDA for Prospect(tm/cryptosporidium.

Pre-market Notification Details

Device IDK912242
510k NumberK912242
Device Name:PROSPECT(TM/CRYPTOSPORIDIUM
ClassificationCryptosporidium Spp.
Applicant ALEXON, INC. 2319 CHARLESTON RD. Mountain View,  CA  94043
ContactTerri A Marello
CorrespondentTerri A Marello
ALEXON, INC. 2319 CHARLESTON RD. Mountain View,  CA  94043
Product CodeMHJ  
CFR Regulation Number866.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-21
Decision Date1992-03-23

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