INCSTAR HSZ I/II IGG ELISA ASSAY

Formalin-saline

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Incstar Hsz I/ii Igg Elisa Assay.

Pre-market Notification Details

Device IDK955363
510k NumberK955363
Device Name:INCSTAR HSZ I/II IGG ELISA ASSAY
ClassificationFormalin-saline
Applicant INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082
ContactMary Frick
CorrespondentMary Frick
INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082
Product CodeIGC  
CFR Regulation Number864.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-22
Decision Date1996-07-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.